We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Thalidomide and Docetaxel in Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00049296
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 11, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Cancer Drug: docetaxel Drug: thalidomide Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles
Study Start Date : July 2002
Primary Completion Date : December 2004
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Osteosarcoma Soft Tissue Sarcoma Kaposi Sarcoma Gastrointestinal Stromal Tumors Nasopharyngeal Carcinoma Glioblastoma Lymphosarcoma Esophageal Cancer Stomach Cancer Multiple Myeloma Gliosarcoma Follicular Lymphoma B-cell Lymphoma Diffuse Large B-Cell Lymphoma Renal Cell Carcinoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Lymphoma, Large-cell Primary Liver Cancer Urethral Cancer Glioma Primary Central Nervous System Lymphoma Ependymoma Medulloblastoma Laryngeal Cancer Breast Cancer, Male Rhabdoid Tumor Anal Cancer Lymphoblastic Lymphoma Bile Duct Cancer Neuroblastoma Pineoblastoma Carcinoid Tumor Anaplastic Astrocytoma Hypopharyngeal Cancer Marginal Zone Lymphoma Ewing Sarcoma Ewing's Family of Tumors Oligodendroglioma Anaplastic Oligodendroglioma Craniopharyngioma Mantle Cell Lymphoma Burkitt Lymphoma Adenoid Cystic Carcinoma Cylindroma Brain Tumor, Adult Meningioma Gallbladder Cancer Leiomyosarcoma Transitional Cell Cancer of the Renal Pelvis and Ureter Neuroepithelioma Chondrosarcoma Small Intestine Cancer Small Intestinal Adenocarcinoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Hemangiopericytoma Anaplastic Ependymoma Embryonal Tumor With Multilayered Rosettes Pineocytoma Metastatic Squamous Neck Cancer With Occult Primary Olfactory Neuroblastoma Pilocytic Astrocytoma Subependymoma Myxopapillary Ependymoma Mucoepidermoid Carcinoma Uterine Sarcoma Midline Lethal Granuloma
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: 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.

    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.

    Other Names:
    • alpha-phthalimidoglutarimide
    • N-phthaloylglutamimide
    • N-phthalylglutamic acid imide

Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: Weekly courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049296


Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Scot C. Remick, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
More Information

Publications:
Responsible Party: Scot C. Remick, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00049296     History of Changes
Other Study ID Numbers: CWRU4Y01
P30CA043703 ( U.S. NIH Grant/Contract )
CWRU-4Y01
NCI-G02-2123
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010

Keywords provided by Case Comprehensive Cancer Center:
adult anaplastic astrocytoma
male breast cancer
adult anaplastic oligodendroglioma
adult meningeal hemangiopericytoma
adult brain stem glioma
adult central nervous system germ cell tumor
adult choroid plexus tumor
adult craniopharyngioma
adult ependymoblastoma
adult glioblastoma
adult pilocytic astrocytoma
adult anaplastic ependymoma
adult medulloblastoma
adult meningioma
adult pineoblastoma
adult pineocytoma
adult subependymoma
adult myxopapillary ependymoma
advanced adult primary liver cancer
anterior urethral cancer
carcinoma of the appendix
chondrosarcoma
classic Kaposi sarcoma
AIDS-related Kaposi sarcoma
immunosuppressive treatment related Kaposi sarcoma
recurrent Kaposi sarcoma
clear cell sarcoma of the kidney
disseminated neuroblastoma
extensive stage small cell lung cancer
gastrointestinal stromal tumor

Additional relevant MeSH terms:
Docetaxel
Thalidomide
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors