Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
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, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel in treating patients with advanced solid tumors.
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 * Determine the safety of this regimen in these patients. * Determine the objective tumor response in patients treated with this regimen. * Determine the time to progression in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of lenalidomide. Patients receive oral lenalidomide on days 1-14 and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Interventions
DRUGdocetaxel
Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.
DRUGlenalidomide
Oral lenalidomide on days 1-14. Courses repeat every 21 days until disease progression or unacceptable toxicity.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | measured at end of phase I |
| Dose-limiting toxicity | measured after every course |
Secondary
| Measure | Time frame |
|---|---|
| Disease response | measured after every 2 courses |
Countries
United States
Outcome results
None listed