Thalidomide and Docetaxel in Treating Patients With Advanced Cancer
Information source: Case Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: docetaxel (Drug); thalidomide (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Case Comprehensive Cancer Center Official(s) and/or principal investigator(s): Scot C. Remick, MD, Principal Investigator, Affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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.
Clinical Details
Official title: Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5065, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 2002
Last updated: June 10, 2010
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