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

• ClinicalTrials.gov Identifier: NCT00496704
• Recruitment Status: Unknown
• First Posted: July 4, 2007
• Last Update Posted: August 21, 2009
• Sponsor: Yonsei University
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: July 3, 2007
• First Posted Date: July 4, 2007
• Last Update Posted Date: August 21, 2009
• Study Start Date: January 2007
• Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 3, 2007): Overall response rate as assessed by RECIST criteria
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00496704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: July 3, 2007)

• Progression-free survival
• Duration of response
• Time to treatment failure
• Overall survival
• Time to response

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Cancer

Intervention

• Drug: capecitabine
• Drug: gemcitabine hydrochloride
• Drug: oxaliplatin

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 3, 2007): 56
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00496704
• Other Study ID Numbers: CDR0000549901; YONSEI-YCC-4-20060231
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Yonsei University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joong B. Ahn, MD; Yonsei University

• PRS Account: National Cancer Institute (NCI)
• Verification Date: August 2009