Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients With Advanced Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: docetaxel
* Drug: lenalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.|
|Drug: lenalidomide|Oral lenalidomide on days 1-14. Courses repeat every 21 days until disease progression or unacceptable toxicity.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  | measured at end of phase I | 
| Dose-limiting toxicity |  | measured after every course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease response |  | measured after every 2 courses | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific