Thalidomide and Docetaxel in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00049296
First received: November 12, 2002
Last updated: June 10, 2010
Last verified: June 2010
  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.


Condition Intervention Phase
Cancer
Drug: docetaxel
Drug: thalidomide
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles

Resource links provided by NLM:

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

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: July 2002
Study Completion Date: January 2006
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Scot C. Remick, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional 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, CWRU-4Y01, NCI-G02-2123
Study First Received: November 12, 2002
Last Updated: June 10, 2010
Health Authority: United States: Federal Government

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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimitotic Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014