Status:
COMPLETED
OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells ...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity of OSI-7904L and oxaliplatin in patients with refractory or recurrent advanced colorectal cancer. * Determine the maximum tolerated dose of...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Radiologic evidence of advanced disease
- At least 1 measurable lesion at least 20 mm OR at least 10 mm by spiral CT scan
- Indicator lesions in a previously irradiated field are allowed provided the irradiated lesion has clearly progressed OR a new lesion has developed in the irradiated field
- Failed 1, and only 1, line of prior chemotherapy for advanced/metastatic disease
- Disease progression during chemotherapy OR within 6 months after completion of treatment
- No symptomatic brain metastases meeting any of the following criteria:
- Unstable
- Inadequately controlled with fixed-dose oral steroids
- Potentially life-threatening
- Required radiotherapy with the past 28 days
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- AST and ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Bilirubin \< 1.5 times ULN
- No hepatitis
- No cirrhosis
- Renal
- Creatinine \< 1.5 times ULN
- Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- HIV negative
- No preexisting neuropathy ≥ grade 2
- No active or uncontrolled infection
- No other serious illness or medical condition
- No chronic alcohol abuse
- No known hypersensitivity to systemic liposomal formulations or compounds chemically related to OSI-7904L or oxaliplatin
- No prior psychiatric or neurologic condition that would preclude study compliance or giving informed consent
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- At least 21 days since prior immunotherapy
- At least 21 days since prior monoclonal antibody therapy
- Chemotherapy
- See Disease Characteristics
- At least 21 days since prior chemotherapy and recovered\*
- No prior oxaliplatin NOTE: \*Alopecia allowed
- Endocrine therapy
- See Disease Characteristics
- At least 21 days since prior hormonal therapy
- Radiotherapy
- See Disease Characteristics
- At least 21 days since prior radiotherapy and recovered
- No prior radiotherapy to more than 25% of bone marrow reserve
- Surgery
- Recovered from prior surgery
- Other
- At least 21 days since prior tyrosine kinase inhibitor therapy
- More than 21 days since prior investigational agents
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00081237
Start Date
February 1 2004
Last Update
June 12 2013
Active Locations (2)
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1
Medizinische Hochschule Hannover
Hanover, Germany, D-30625
2
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX