Thalidomide and Docetaxel in Treating Patients With Advanced Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049296
• Other study ID #: CWRU4Y01
• Secondary ID: P30CA043703CWRU-
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2002
• Last updated: June 10, 2010
• Start date: July 2002
• Est. completion date: January 2006

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2006
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sanborn SL, Cooney MM, Dowlati A, Brell JM, Krishnamurthi S, Gibbons J, Bokar JA, Nock C, Ness A, Remick SC. Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles. Invest New Drugs. 2008 Aug;26(4):355-62. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.		Weekly courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.	Yes