Thalidomide and Docetaxel in Treating Patients With Advanced Cancer

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Completed

Phase 1

Conditions

Cancer

Treatments

Drug: thalidomide

Drug: docetaxel

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00049296

CWRU4Y01

P30CA043703 (U.S. NIH Grant/Contract)

CWRU-4Y01

NCI-G02-2123

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.
Determine the dose-limiting toxicity and safety profile of this regimen in these patients.
Determine the plasma pharmacokinetics of this regimen in these patients.
Determine the objective tumor response and prolonged freedom from progression in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive oral thalidomide twice daily and docetaxel IV over 30 minutes once weekly. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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