Thalidomide and Docetaxel in Treating Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with docetaxel may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining thalidomide with docetaxel in treating patients who have advanced cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Thalidomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignancy not amenable to curative surgery, radiotherapy, or chemotherapy

• Tumor types may include any of the following:

• Any solid tumor including, but not limited to, head and neck, breast, lung, gastrointestinal, genitourinary, melanoma, and sarcoma

• Primary CNS neoplasms if the following are true:

• Received primary radiotherapy

• No concurrent corticosteroids or has been on a stable corticosteroid dose for at least 30 days

• No concurrent enzyme-inducible anti-epileptic medications (i.e., carbamazepine or phenytoin)

• Multiple myeloma

• Non-Hodgkin's lymphoma

• No refractory or relapsed acute or chronic leukemia

• Measurable or evaluable disease

• No life-prolonging therapy available

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• At least 4 months

Hematopoietic

• WBC at least 4,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic

• Bilirubin no greater than upper limit of normal (ULN)

• AST and/or ALT no greater than 2.5 times ULN if alkaline phosphatase less than ULN OR

• Alkaline phosphatase no greater than 4 times ULN if AST/ALT less than ULN

Renal

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No New York Heart Association class III or IV heart disease

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and 4 weeks after study

• Willing and able to comply with FDA-mandated STEPS program

• No peripheral neuropathy grade 2 or greater

• No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No more than 2 prior courses of mitomycin

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• At least 4 weeks since prior large-field radiotherapy and recovered

Surgery

• Not specified

Other

• At least 3 weeks since other prior anticancer therapy and recovered