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Thalidomide and Docetaxel in Treating Patients With Advanced Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00049296
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Case Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Scot C. Remick, MD
Principal Investigator Affiliation Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cancer
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Address

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

Cleveland, Ohio, 44106-5065

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