Thalidomide And Docetaxel In Treating Patients With Advanced Cancer

Study Overview

Thalidomide and Docetaxel in Treating Patients With Advanced Cancer

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.

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.

Cancer

DRUG: docetaxel
DRUG: thalidomide

CWRU4Y01
P30CA043703 (U.S. NIH Grant/Contract)
CWRU-4Y01
NCI-G02-2123

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-11-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2010-06-10
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2010-06-11
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2010-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.		Weekly courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

Male or female

Not specified

ECOG 0-1

At least 4 months

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

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

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

No New York Heart Association class III or IV heart disease

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

Not specified

At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
No more than 2 prior courses of mitomycin

See Disease Characteristics

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

Not specified

At least 3 weeks since other prior anticancer therapy and recovered

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Scot C. Remick, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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Clinical Trial Record