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Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Irinotecan 70 mg/m2
Irinotecan 240 mg/m2
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced or metastatic colorectal cancer Unresectable disease At least 1 bidimensionally measurable lesion At least 2 cm in perpendicular diameters No evidence of CNS metastases PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: 0-1 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No clinically significant cardiac disease No congestive heart failure No New York Heart Association class III or IV heart disease No symptomatic coronary artery disease No uncontrolled cardiac arrhythmia No myocardial infarction within the past year Gastrointestinal: No evidence of dysphagia No malabsorption or intestinal obstruction that would affect absorption or excretion of study drugs No chronic diarrhea Other: No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer No psychiatric disability that would preclude study compliance No other significant medical condition Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced or metastatic disease Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 4 weeks since prior major surgery to the gastrointestinal tract Other: No concurrent therapy for history of seizures or CNS disorder

Sites / Locations

  • Inselspital, Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;

Irinotecan i.v. 240 mg/m2 day 1 and day 22; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
May 14, 2012
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00030797
Brief Title
Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
Official Title
A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced or metastatic colorectal cancer.
Detailed Description
OBJECTIVES: Compare the efficacy of different schedules of irinotecan in combination with capecitabine as first-line therapy, in terms of objective response rate, in patients with advanced or metastatic colorectal cancer. Compare the time to treatment failure, time to progression, and overall survival of patients treated with these regimens. Compare the safety profile, in terms of toxicity, of these regimens in these patients. Determine the quality of life in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1); disease symptoms, including pain, weight loss, loss of appetite, malaise, and fever of unknown origin (yes vs no); weight loss during the past 6 months (more than 5% vs 5% or less); and disease-free interval (more than 6 months vs 6 months or less). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive irinotecan IV over 1 hour on days 1, 8, 15, 22, and 29 and oral capecitabine twice daily on days 1-14 and 22-35. Arm II: Patients receive irinotecan IV over 1 hour on days 1 and 22 and oral capecitabine as in arm I. Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, on day 1 of each course, and at the first visit after treatment failure. Patients are followed every 12 weeks for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Irinotecan i.v. 240 mg/m2 day 1 and day 22; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
Intervention Type
Drug
Intervention Name(s)
Irinotecan 70 mg/m2
Intervention Description
Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29
Intervention Type
Drug
Intervention Name(s)
Irinotecan 240 mg/m2
Intervention Description
Irinotecan i.v. 240 mg/m2 day 1 and day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced or metastatic colorectal cancer Unresectable disease At least 1 bidimensionally measurable lesion At least 2 cm in perpendicular diameters No evidence of CNS metastases PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: 0-1 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No clinically significant cardiac disease No congestive heart failure No New York Heart Association class III or IV heart disease No symptomatic coronary artery disease No uncontrolled cardiac arrhythmia No myocardial infarction within the past year Gastrointestinal: No evidence of dysphagia No malabsorption or intestinal obstruction that would affect absorption or excretion of study drugs No chronic diarrhea Other: No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer No psychiatric disability that would preclude study compliance No other significant medical condition Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced or metastatic disease Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 4 weeks since prior major surgery to the gastrointestinal tract Other: No concurrent therapy for history of seizures or CNS disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus M. Borner, MD
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Study Chair
Facility Information:
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15668285
Citation
Borner MM, Bernhard J, Dietrich D, Popescu R, Wernli M, Saletti P, Rauch D, Herrmann R, Koeberle D, Honegger H, Brauchli P, Lanz D, Roth AD; Swiss Group for Clinical Cancer Research (SAKK), Berne, Switzerland. A randomized phase II trial of capecitabine and two different schedules of irinotecan in first-line treatment of metastatic colorectal cancer: efficacy, quality-of-life and toxicity. Ann Oncol. 2005 Feb;16(2):282-8. doi: 10.1093/annonc/mdi047.
Results Reference
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Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer

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