Status:
COMPLETED
Oxaliplatin, Irinotecan, and Capecitabine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable adv...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer
- Measurable disease (phase II only)
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI
- No presence or history of CNS metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 to 70
- Performance status
- WHO 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.25 times upper limit of normal (ULN) (1.5 times ULN if liver metastases are present)
- AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
- Renal
- Creatinine clearance \> 60 mL/min
- Cardiovascular
- No New York Heart Association class III-IV congestive heart failure
- No symptomatic coronary artery disease
- No uncontrolled cardiac arrhythmia
- No myocardial infarction within the past year
- No other clinically significant cardiac disease
- Immunologic
- No active autoimmune disease
- No uncontrolled infection
- No prior severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil
- No known hypersensitivity to any component of study drugs
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Patients must use effective contraception during and for 1 year after study participation
- No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
- No peripheral neuropathy \> grade 1 of any origin (e.g., alcohol or diabetes)
- No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or absorption of oral medication
- No psychiatric disability that would preclude study compliance
- No uncontrolled diabetes
- No other serious underlying medical condition that would preclude study participation
- No known dihydropyrimidine dehydrogenase deficiency
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent prophylactic hematopoietic growth factors
- Chemotherapy
- More than 6 months since prior adjuvant fluoropyrimidine chemotherapy
- No other prior chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- No concurrent radiotherapy
- Concurrent radiotherapy of a single painful lesion allowed
- Surgery
- Not specified
- Other
- More than 30 days since prior clinical trial participation
- No other concurrent experimental drugs
- No other concurrent anticancer therapy
- No concurrent sorivudine or its chemically-related analogues (e.g., lamivudine)
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00217711
Start Date
May 1 2005
End Date
October 1 2011
Last Update
June 5 2012
Active Locations (4)
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1
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
2
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
3
Hirslanden Klinik Aarau
Lausanne, Switzerland, CH-1011
4
City Hospital Triemli
Zurich, Switzerland, CH-8063