Status:
COMPLETED
Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity and maximum tolerated dose of lenalidomide when given in combination with docetaxel in patients with advanced solid tumors. Secondary * D...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor
- Advanced disease
- Refractory to standard therapy OR no standard therapy exists
- Measurable or evaluable disease
- No active brain metastases
- Previously treated (e.g., surgery or radiotherapy) brain metastases are allowed provided they are currently asymptomatic and inactive by CT scan or MRI
- PATIENT CHARACTERISTICS:
- Performance status
- ECOG 0-2
- Life expectancy
- At least 4 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 8 g/dL
- Hepatic
- Bilirubin normal
- Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
- Renal
- Creatinine ≤ 2 mg/dL
- Cardiovascular
- No New York Heart Association class III or IV heart disease
- Immunologic
- No prior desquamating rash or ≥ grade 2 allergic reaction while receiving thalidomide
- No history of hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
- No history of allergic reaction to compounds of similar chemical or biologic composition to study drugs
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other uncontrolled illness or other condition that would preclude study compliance
- No peripheral neuropathy ≥ grade 2
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent hematopoietic growth factors during course 1 of study treatment
- No concurrent immunotherapy
- Chemotherapy
- At least 6 weeks since prior mitomycin or nitrosoureas
- No more than 2 prior courses of mitomycin
- No other concurrent chemotherapy
- Radiotherapy
- No prior pelvic radiotherapy
- Other
- At least 4 weeks since prior anticancer therapy
- No concurrent warfarin for anticoagulation (heparin is allowed)
- Recovered from all prior treatment
- No other concurrent anticancer therapy except bisphosphonates
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00253344
Start Date
June 1 2005
End Date
June 1 2008
Last Update
June 11 2010
Active Locations (1)
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1
Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065