Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Completed

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: lenalidomide

Drug: docetaxel

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00253344

P30CA043703 (U.S. NIH Grant/Contract)

AVENTIS-CASE-2Y04

CASE2Y04 (Other Identifier)

CELGENE-CASE-2Y04

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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