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Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

Primary Purpose

Colorectal Neoplasms

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Modified Bolus 5-FU/LV with Irinotecan

FOLFIRI + bevacizumab

miFL + bevacizumab

Infusional 5-FU/LV with Irinotecan

Oral Capecitabine with Irinotecan

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (Stage IV distant disease) Present or past histological documentation of adenocarcinoma of the colon or rectum. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless: An interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease. The primary cancer was a Duke's A or B1. Physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases. Exclusion Criteria: Patients who received any prior systemic anticancer therapy for metastatic colorectal cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents). Patients cannot have concurrent malignancies at study entry. Exceptions: Patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). Patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Other

Arm Label

Modified Bolus 5-FU/LV with Irinotecan

FOLFIRI + bevacizumab

miFL + bevacizumab

Infusional 5-FU/LV with Irinotecan

Oral Capecitabine with Irinotecan

Arm Description

Outcomes

Primary Outcome Measures

Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL

Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).

Secondary Outcome Measures

Time to Progression: FOLFIRI, mIFL and CapeIRI

Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).

Overall Response: FOLFIRI, mIFL and CapeIRI

A subject will be considered achieving an overall response if the subject has a sustained Complete Response (CR) or Partial Response (PR) for at least 4 weeks, confirmed by tumor assessments. (CR: Disappearance of all target lesions. PR: greater than or equal to 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Pre-treatment sum LD. )

Survival Time: FOLFIRI, mIFL and CapeIRI

Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.

1 Year Survival: FOLFIRI, mIFL and CapeIRI

Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.

Time to Progression : Celecoxib and Placebo

Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).

Overall Response: Celecoxib and Placebo

A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )

Survival Time: Celecoxib and Placebo

Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.

Time to Progression: Bevacizumab With FOLFIRI, mIFL

Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).

Overall Response: Bevacizumab With FOLFIRI, mIFL

1 Year Survival: Bevacizumab With FOLFIRI, mIFL

Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.

Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL

Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. Zero subjects analyzed indicates median could not be analyzed based on number of subjects who died.

Dose Reduction Due to Treatment Emergent Adverse Events

Number of subjects that had at least one Treatment-Emergent Adverse Event (TEAE) that led to a dose reduction. TEAE includes all reported Adverse Events that occurred within 30 days of last study medication.

Overall Relative Dose Intensity of Irinotecan

Relative dose intensity for a cycle was calculated as the percentage of the actual dose intensity of the cycle divided by the planned dose intensity of the cycle. Overall relative dose intensity was calculated as the average relative dose intensities over all cycles. (Dose intensity for each cycle was calculated as the actual dose level of the study medication received in that cycle divided by the number of weeks in the cycle.)

Full Information

NCT ID

NCT00101686

First Posted

January 12, 2005

Last Updated

January 4, 2010

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00101686

Brief Title

Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

Official Title

A Randomized, Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine: Infusional 5-FU (FOLFIRI), Modified-Bolus 5-FU (Day 1 & 8), And Oral Capecitabine (Day 1-14); With Celecoxib Versus Placebo As First-Line Treatment For Patients With Metastatic Colorectal Cancer Study Amended April 23, 2004 To Include Bevacizumab

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

February 2003 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI [a chemotherapy regime that combines bolus irinotecan and leucovorin [LV] with infusional 5-fluorouracil (5-FU)] + bevacizumab and mlFL + bevacizumab. Measures of efficacy and safety will be reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

547 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Modified Bolus 5-FU/LV with Irinotecan

Arm Type

Experimental

Arm Title

FOLFIRI + bevacizumab

Arm Type

Experimental

Arm Title

miFL + bevacizumab

Arm Type

Experimental

Arm Title

Infusional 5-FU/LV with Irinotecan

Arm Type

Experimental

Arm Title

Oral Capecitabine with Irinotecan

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Modified Bolus 5-FU/LV with Irinotecan

Intervention Description

Day 1 & 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID [two times a day] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).

Intervention Type

Drug

Intervention Name(s)

FOLFIRI + bevacizumab

Intervention Description

Day 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing. I m m e d i a t e l y f o l l o w e d b y : 5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing. I m m e d i a t e l y f o l l o w e d b y : 5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID [two times a day] oral Every 2 weeks

Intervention Type

Drug

Intervention Name(s)

miFL + bevacizumab

Intervention Description

Day 1 Bevacizumab 7.5mg/kg IV *over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID [two times a day] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID [two times a day] continues daily without interruption Every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Infusional 5-FU/LV with Irinotecan

Intervention Description

Day 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID [two times a day](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).

Intervention Type

Drug

Intervention Name(s)

Oral Capecitabine with Irinotecan

Intervention Description

Day 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID [two times a day] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).

Primary Outcome Measure Information:

Title

Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL

Description

Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).

Time Frame

every 6 weeks until disease progression

Secondary Outcome Measure Information:

Title

Time to Progression: FOLFIRI, mIFL and CapeIRI

Description

Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).

Time Frame

every 6 weeks until disease progression

Title

Overall Response: FOLFIRI, mIFL and CapeIRI

Description

Time Frame

every 6 weeks during chemotherapy until disease progression

Title

Survival Time: FOLFIRI, mIFL and CapeIRI

Description

Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.

Time Frame

assessed at least every week during treatment and at least every 3 months during follow-up

Title

1 Year Survival: FOLFIRI, mIFL and CapeIRI

Description

Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.

Time Frame

1 year from date of randomization

Title

Time to Progression : Celecoxib and Placebo

Description

Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).

Time Frame

every 6 weeks until disease progression

Title

Overall Response: Celecoxib and Placebo

Description

Time Frame

every 6 weeks during chemotherapy until disease progression

Title

Survival Time: Celecoxib and Placebo

Description

Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.

Time Frame

assessed at least every week during treatment and at least every 3 months during follow-up

Title

Time to Progression: Bevacizumab With FOLFIRI, mIFL

Description

Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).

Time Frame

every 6 weeks until disease progression

Title

Overall Response: Bevacizumab With FOLFIRI, mIFL

Description

Time Frame

every 6 weeks during chemotherapy until disease progression

Title

1 Year Survival: Bevacizumab With FOLFIRI, mIFL

Description

Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.

Time Frame

1 year from date of randomization

Title

Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL

Description

Time Frame

Last Follow-Up Visit

Title

Dose Reduction Due to Treatment Emergent Adverse Events

Description

Time Frame

Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI

Title

Overall Relative Dose Intensity of Irinotecan

Description

Time Frame

End of treatment cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Birmgingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Pfizer Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Pfizer Investigational Site

City

Birmngham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Pfizer Investigational Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Pfizer Investigational Site

City

Flagstaff

State/Province

Arizona

ZIP/Postal Code

86001

Country

United States

Facility Name

Pfizer Investigational Site

City

Sedona

State/Province

Arizona

ZIP/Postal Code

86336

Country

United States

Facility Name

Pfizer Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Pfizer Investigational Site

City

Hot Spring

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

Pfizer Investigational Site

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72764

Country

United States

Facility Name

Pfizer Investigational Site

City

Arroyo Grande

State/Province

California

ZIP/Postal Code

93420

Country

United States

Facility Name

Pfizer Investigational Site

City

Fountian Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Pfizer Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

Pfizer Investigational Site

City

Los Gatos

State/Province

California

ZIP/Postal Code

95032

Country

United States

Facility Name

Pfizer Investigational Site

City

Mission Hills

State/Province

California

ZIP/Postal Code

91345

Country

United States

Facility Name

Pfizer Investigational Site

City

Modesto

State/Province

California

ZIP/Postal Code

95355

Country

United States

Facility Name

Pfizer Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Pfizer Investigational Site

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Pfizer Investigational Site

City

San Jose

State/Province

California

ZIP/Postal Code

95125

Country

United States

Facility Name

Pfizer Investigational Site

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

Pfizer Investigational Site

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06581

Country

United States

Facility Name

Pfizer Investigational Site

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902-3628

Country

United States

Facility Name

Pfizer Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Pfizer Investigational Site

City

Altamonte Springs

State/Province

Florida

ZIP/Postal Code

32701

Country

United States

Facility Name

Pfizer Investigational Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Pfizer Investigational Site

City

Lauderhill

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami Beach

State/Province

Florida

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Pfizer Investigational Site

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Pfizer Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34474

Country

United States

Facility Name

Pfizer Investigational Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Pfizer Investigational Site

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

Pfizer Investigational Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Pfizer Investigational Site

City

Niles

State/Province

Illinois

ZIP/Postal Code

60714

Country

United States

Facility Name

Pfizer Investigational Site

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61108-2472

Country

United States

Facility Name

Pfizer Investigational Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Pfizer Investigational Site

City

Fishers

State/Province

Indiana

ZIP/Postal Code

46038

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46815

Country

United States

Facility Name

Pfizer Investigational Site

City

Terre Haute

State/Province

Indiana

ZIP/Postal Code

47802

Country

United States

Facility Name

Pfizer Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

Pfizer Investigational Site

City

Alexandria

State/Province

Louisiana

ZIP/Postal Code

71301

Country

United States

Facility Name

Pfizer Investigational Site

City

Shrevport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Pfizer Investigational Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Pfizer Investigational Site

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Pfizer Investigational Site

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

Facility Name

Pfizer Investigational Site

City

Pittsfield

State/Province

Massachusetts

ZIP/Postal Code

01201

Country

United States

Facility Name

Pfizer Investigational Site

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49603

Country

United States

Facility Name

Pfizer Investigational Site

City

Burnsville

State/Province

Minnesota

ZIP/Postal Code

55337

Country

United States

Facility Name

Pfizer Investigational Site

City

Robbinsdale

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65201

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65203

Country

United States

Facility Name

Pfizer Investigational Site

City

Joplin

State/Province

Missouri

ZIP/Postal Code

64804

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63136

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Pfizer Investigational Site

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

Pfizer Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Pfizer Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

Pfizer Investigational Site

City

Hooksett

State/Province

New Hampshire

ZIP/Postal Code

03106

Country

United States

Facility Name

Pfizer Investigational Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756-0001

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03060

Country

United States

Facility Name

Pfizer Investigational Site

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07901

Country

United States

Facility Name

Pfizer Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Pfizer Investigational Site

City

Farmington

State/Province

New Mexico

ZIP/Postal Code

87401

Country

United States

Facility Name

Pfizer Investigational Site

City

Santa Fe

State/Province

New Mexico

ZIP/Postal Code

87501

Country

United States

Facility Name

Pfizer Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Pfizer Investigational Site

City

Manhaset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Pfizer Investigational Site

City

Rockville Centre

State/Province

New York

ZIP/Postal Code

11570

Country

United States

Facility Name

Pfizer Investigational Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Pfizer Investigational Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27511

Country

United States

Facility Name

Pfizer Investigational Site

City

Fayetteville

State/Province

North Carolina

ZIP/Postal Code

28302-2000

Country

United States

Facility Name

Pfizer Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27403

Country

United States

Facility Name

Pfizer Investigational Site

City

Hendersonville

State/Province

North Carolina

ZIP/Postal Code

28791

Country

United States

Facility Name

Pfizer Investigational Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

Pfizer Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Pfizer Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Pfizer Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

Pfizer Investigational Site

City

Bartlesville

State/Province

Oklahoma

ZIP/Postal Code

74006

Country

United States

Facility Name

Pfizer Investigational Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Pfizer Investigational Site

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Pfizer Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Pfizer Investigational Site

City

Abington

State/Province

Pennsylvania

ZIP/Postal Code

19001

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19014-4283

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19141

Country

United States

Facility Name

Pfizer Investigational Site

City

Reading

State/Province

Pennsylvania

ZIP/Postal Code

19603

Country

United States

Facility Name

Pfizer Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Pfizer Investigational Site

City

Collierville

State/Province

Tennessee

ZIP/Postal Code

38017

Country

United States

Facility Name

Pfizer Investigational Site

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Pfizer Investigational Site

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38301

Country

United States

Facility Name

Pfizer Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37916

Country

United States

Facility Name

Pfizer Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Pfizer Investigational Site

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606-5208

Country

United States

Facility Name

Pfizer Investigational Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

Pfizer Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Pfizer Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Pfizer Investigational Site

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77702-1449

Country

United States

Facility Name

Pfizer Investigational Site

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230-2510

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231-4400

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75237

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Pfizer Investigational Site

City

Denton

State/Province

Texas

ZIP/Postal Code

76210

Country

United States

Facility Name

Pfizer Investigational Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79902

Country

United States

Facility Name

Pfizer Investigational Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79915

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Pfizer Investigational Site

City

Fredericksburg

State/Province

Texas

ZIP/Postal Code

78624-3847

Country

United States

Facility Name

Pfizer Investigational Site

City

Garland

State/Province

Texas

ZIP/Postal Code

75042

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

Pfizer Investigational Site

City

Irving

State/Province

Texas

ZIP/Postal Code

75061-224

Country

United States

Facility Name

Pfizer Investigational Site

City

Lewisville

State/Province

Texas

ZIP/Postal Code

75067

Country

United States

Facility Name

Pfizer Investigational Site

City

Longview

State/Province

Texas

ZIP/Postal Code

75601

Country

United States

Facility Name

Pfizer Investigational Site

City

McAllen

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

Facility Name

Pfizer Investigational Site

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75050

Country

United States

Facility Name

Pfizer Investigational Site

City

Midland

State/Province

Texas

ZIP/Postal Code

79701

Country

United States

Facility Name

Pfizer Investigational Site

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

Facility Name

Pfizer Investigational Site

City

Odessa

State/Province

Texas

ZIP/Postal Code

79761

Country

United States

Facility Name

Pfizer Investigational Site

City

Paris

State/Province

Texas

ZIP/Postal Code

75460

Country

United States

Facility Name

Pfizer Investigational Site

City

Sherman

State/Province

Texas

ZIP/Postal Code

75090-0504

Country

United States

Facility Name

Pfizer Investigational Site

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

Pfizer Investigational Site

City

Tyler

State/Province

Texas

ZIP/Postal Code

75701-2001

Country

United States

Facility Name

Pfizer Investigational Site

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

Country

United States

Facility Name

Pfizer Investigational Site

City

Waco

State/Province

Texas

ZIP/Postal Code

76712

Country

United States

Facility Name

Pfizer Investigational Site

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Pfizer Investigational Site

City

Wichita Falls

State/Province

Texas

ZIP/Postal Code

76310

Country

United States

Facility Name

Pfizer Investigational Site

City

Colchester

State/Province

Vermont

ZIP/Postal Code

05446

Country

United States

Facility Name

Pfizer Investigational Site

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Pfizer Investigational Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Pfizer Investigational Site

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Facility Name

Pfizer Investigational Site

City

Edmonds

State/Province

Washington

ZIP/Postal Code

98026

Country

United States

Facility Name

Pfizer Investigational Site

City

Lacy

State/Province

Washington

ZIP/Postal Code

98503

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Facility Name

Pfizer Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Pfizer Investigational Site

City

Yakima

State/Province

Washington

ZIP/Postal Code

98902

Country

United States

Facility Name

Pfizer Investigational Site

City

Glendale

State/Province

Wisconsin

ZIP/Postal Code

53212

Country

United States

Facility Name

Pfizer Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Pfizer Investigational Site

City

Waratah

State/Province

New South Wales

ZIP/Postal Code

2298

Country

Australia

Facility Name

Pfizer Investigational Site

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Pfizer Investigational Site

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

Pfizer Investigational Site

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Pfizer Investigational Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Pfizer Investigational Site

City

Frankston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

Pfizer Investigational Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 8X3

Country

Canada

Facility Name

Pfizer Investigational Site

City

St. Johns

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V76

Country

Canada

Facility Name

Pfizer Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Sydney

State/Province

Nova Scotia

ZIP/Postal Code

B1P 1P3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6W 3X4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5P9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2G 1G3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5B 1B8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 2P9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 1C4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Scarborough

State/Province

Ontario

ZIP/Postal Code

M1P 2V5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Thunder Bay

State/Province

Ontario

ZIP/Postal Code

P7A 7T1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 2X3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Chicoutimi

State/Province

Quebec

ZIP/Postal Code

G7H 5H6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Fleurimont

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Laval

State/Province

Quebec

ZIP/Postal Code

H7M 3L9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 4B3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1S6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3J4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 5T1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 7T1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Quebec

Country

Canada

Facility Name

Pfizer Investigational Site

City

Auckland

ZIP/Postal Code

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Dunedin

ZIP/Postal Code

9001

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Riccarton

ZIP/Postal Code

8020

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Wellington

ZIP/Postal Code

6039

Country

New Zealand

12. IPD Sharing Statement

Learn more about this trial

Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

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Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

Colorectal Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial