Thalidomide and Docetaxel in Treating Patients With Advanced Cancer

NCT ID: NCT00049296

Last Updated: 2010-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2006-01-31

Brief 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.

Detailed 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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Patients receive 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.

Intervention Type: DRUG

thalidomide

Patients receive oral thalidomide twice daily. 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.

Intervention Type: DRUG

Other Intervention Names

alpha-phthalimidoglutarimide; N-phthaloylglutamimide; N-phthalylglutamic acid imide

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Principal Investigators

Scot C. Remick, MD

Role: PRINCIPAL_INVESTIGATOR

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Locations

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

References

Sanborn SL, Cooney MM, Dowlati A, Brell JM, Krishnamurthi S, Gibbons J, Bokar JA, Nock C, Ness A, Remick SC. Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles. Invest New Drugs. 2008 Aug;26(4):355-62. doi: 10.1007/s10637-008-9137-0. Epub 2008 May 10.

Reference Type: RESULT

PMID: 18470481 (View on PubMed)

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CWRU-4Y01

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2123

Identifier Type: -

Identifier Source: secondary_id

CWRU4Y01

Identifier Type: -

Identifier Source: org_study_id