Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Thalidomide and Docetaxel in Treating Patients With Advanced Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	CWRU-4Y01 NCI-G02-2123, NCT00049296

Objectives

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

Entry 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

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

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/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Sanborn SL, Cooney MM, Dowlati A, et al.: Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles. Invest New Drugs 26 (4): 355-62, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Scot Remick, MD, Protocol chair		Ph: 216-844-5412

Registry Information
Official Title		Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles
Trial Start Date		2002-07-25
Registered in ClinicalTrials.gov		NCT00049296
Date Submitted to PDQ		2002-09-16
Information Last Verified		2005-02-02
NCI Grant/Contract Number		P30-CA43703

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