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Completed

NCT Number: NCT00049296

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.

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Key information

Conditions

Cancer AIDS-related Kaposi sarcoma Adenocarcinoma Anus Diseases Anus Neoplasms Appendiceal Neoplasms Astrocytoma Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Blood Protein Disorders Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Burkitt Lymphoma Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Cardiovascular Diseases Cecal Diseases Cecal Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Chondrosarcoma Choroid Plexus Neoplasms Chronic Disease Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Cranial Nerve Diseases Craniopharyngioma DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Ependymoma Epstein-Barr Virus Infections Esophageal Diseases Esophageal Neoplasms Esthesioneuroblastoma, Olfactory Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gallbladder Diseases Gallbladder Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Glioblastoma Glioma Glioma, Subependymal Gliosarcoma Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Medulloblastoma Melanoma Meningeal Neoplasms Meningioma Mouth Diseases Mouth Neoplasms Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Neuroendocrine Tumors Nevi and Melanomas Olfactory Nerve Diseases Oligodendroglioma Osteosarcoma Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pinealoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Sarcoma Sarcoma, Kaposi Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Thoracic Neoplasms Tumor Virus Infections Urethral Diseases Urethral Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

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.

thalidomide

Drug

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles

Important dates

Study start
2002
Primary completion
2004
Study completion
2006
First posted
Jan 27, 2003
Registry last updated
Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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