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Gemcitabine, Capecitabine, and Oxaliplatin as Second-Line Therapy in Treating Patients With Advanced Colorectal Cancer Previously Treated With Irinotecan

Primary Purpose

Colorectal Cancer

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

capecitabine

gemcitabine hydrochloride

oxaliplatin

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, recurrent colon cancer, stage III colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

Histologically confirmed advanced colorectal adenocarcinoma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
Must have received prior irinotecan hydrochloride with a progression-free interval of < 3 months
No symptomatic brain metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 3 months
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Total bilirubin ≤ 2 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
Creatinine ≤ 1.5 times ULN
No significant cardiac abnormalities by ECG
No known hypersensitivity to the study drugs or any of their components
No myocardial infarction within the past 12 months
No uncontrolled congestive heart failure
No cardiovascular disorder ≥ grade 3 despite treatment
No other malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
No significant disease, that in the opinion of the investigator, would preclude study treatment (e.g., active infections, interstitial lung disease, or peripheral neuropathy)
No history of significant neurological or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder)
No legal incapacity or limited legal capacity that would preclude study participation

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from all prior therapy
More than 30 days since prior participation in another clinical trial
No concurrent warfarin, phenprocoumon, phenytoin, or sorivudine

Sites / Locations

Yonsei Cancer Center at Yonsei University Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Overall response rate as assessed by RECIST criteria

Secondary Outcome Measures

Progression-free survival

Duration of response

Time to treatment failure

Overall survival

Time to response

Full Information

NCT ID

NCT00496704

First Posted

July 3, 2007

Last Updated

August 20, 2009

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT00496704

Brief Title

Gemcitabine, Capecitabine, and Oxaliplatin as Second-Line Therapy in Treating Patients With Advanced Colorectal Cancer Previously Treated With Irinotecan

Official Title

A Phase I/II Study to Determine the Safety and Efficacy of Second-Line Treatment With XELOX Plus Gemcitabine in Irinotecan Pre-Treated Advanced Colorectal Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Yonsei University

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with capecitabine and oxaliplatin as second-line therapy and to see how well it works in treating patients with advanced colorectal cancer previously treated with irinotecan.

Detailed Description

OBJECTIVES: Primary Define the dose-limiting toxicity and maximum tolerated dose of gemcitabine hydrochloride when administered with capecitabine and oxaliplatin as second-line therapy in patients with advanced colorectal cancer previously treated with irinotecan hydrochloride. (Phase I) Determine the recommended phase II dose of gemcitabine hydrochloride in these patients. (Phase I) Assess overall response rate in patients treated with this regimen. (Phase II) Secondary Assess the progression-free survival of patients treated with this regimen. (Phase II) Assess the time to treatment failure, duration of response, and time to response in patients treated with this regimen. (Phase II) Assess the overall survival of patients treated with this regimen. (Phase II) Assess the safety of this regimen in these patients. (Phase II) OUTLINE: This is a multicenter, phase I, dose-escalation study of gemcitabine hydrochloride, followed by a phase II, open-label study. Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, oral capecitabine twice daily on days 1-14, and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days. Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the maximum tolerated dose (MTD) is determined. Phase II: Patients receive gemcitabine hydrochloride at the MTD determined in phase I and capecitabine and oxaliplatin as in phase I.

6. Conditions and Keywords

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

Colorectal Cancer

Keywords

adenocarcinoma of the colon, recurrent colon cancer, stage III colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Masking

None (Open Label)

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

capecitabine

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Primary Outcome Measure Information:

Title

Overall response rate as assessed by RECIST criteria

Secondary Outcome Measure Information:

Title

Progression-free survival

Title

Duration of response

Title

Time to treatment failure

Title

Overall survival

Title

Time to response

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal adenocarcinoma Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan Must have received prior irinotecan hydrochloride with a progression-free interval of < 3 months No symptomatic brain metastases PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 3 months ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9 g/dL Total bilirubin ≤ 2 times upper limit of normal (ULN) AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present) Creatinine ≤ 1.5 times ULN No significant cardiac abnormalities by ECG No known hypersensitivity to the study drugs or any of their components No myocardial infarction within the past 12 months No uncontrolled congestive heart failure No cardiovascular disorder ≥ grade 3 despite treatment No other malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix No significant disease, that in the opinion of the investigator, would preclude study treatment (e.g., active infections, interstitial lung disease, or peripheral neuropathy) No history of significant neurological or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder) No legal incapacity or limited legal capacity that would preclude study participation PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from all prior therapy More than 30 days since prior participation in another clinical trial No concurrent warfarin, phenprocoumon, phenytoin, or sorivudine

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joong B. Ahn, MD

Organizational Affiliation

Yonsei University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei Cancer Center at Yonsei University Medical Center

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joong B. Ahn, MD

Phone

82-2-2228-8134

12. IPD Sharing Statement

Learn more about this trial

Gemcitabine, Capecitabine, and Oxaliplatin as Second-Line Therapy in Treating Patients With Advanced Colorectal Cancer Previously Treated With Irinotecan

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