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
Sponsored by
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
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
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
No
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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