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Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00253344
First Posted: November 15, 2005
Last Update Posted: June 11, 2010
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Case Comprehensive Cancer Center
  Purpose

RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel in treating patients with advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: docetaxel Drug: lenalidomide Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: measured at end of phase I ]
  • Dose-limiting toxicity [ Time Frame: measured after every course ]

Secondary Outcome Measures:
  • Disease response [ Time Frame: measured after every 2 courses ]

Enrollment: 33
Study Start Date: June 2005
Study Completion Date: June 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: docetaxel
    Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.
    Drug: lenalidomide
    Oral lenalidomide on days 1-14. Courses repeat every 21 days until disease progression or unacceptable toxicity.
Detailed Description:

OBJECTIVES:

Primary

  • Determine the dose-limiting toxicity and maximum tolerated dose of lenalidomide when given in combination with docetaxel in patients with advanced solid tumors.

Secondary

  • Determine the safety of this regimen in these patients.
  • Determine the objective tumor response in patients treated with this regimen.
  • Determine the time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of lenalidomide.

Patients receive oral lenalidomide on days 1-14 and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor

    • Advanced disease
    • Refractory to standard therapy OR no standard therapy exists
  • Measurable or evaluable disease
  • No active brain metastases

    • Previously treated (e.g., surgery or radiotherapy) brain metastases are allowed provided they are currently asymptomatic and inactive by CT scan or MRI

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • At least 4 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL

Hepatic

  • Bilirubin normal
  • Meets 1 of the following criteria:

    • Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST or ALT normal

Renal

  • Creatinine ≤ 2 mg/dL

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Immunologic

  • No prior desquamating rash or ≥ grade 2 allergic reaction while receiving thalidomide
  • No history of hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
  • No history of allergic reaction to compounds of similar chemical or biologic composition to study drugs

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other uncontrolled illness or other condition that would preclude study compliance
  • No peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent hematopoietic growth factors during course 1 of study treatment
  • No concurrent immunotherapy

Chemotherapy

  • At least 6 weeks since prior mitomycin or nitrosoureas

    • No more than 2 prior courses of mitomycin
  • No other concurrent chemotherapy

Radiotherapy

  • No prior pelvic radiotherapy

Other

  • At least 4 weeks since prior anticancer therapy
  • No concurrent warfarin for anticoagulation (heparin is allowed)
  • Recovered from all prior treatment
  • No other concurrent anticancer therapy except bisphosphonates
  • No other concurrent investigational agents
  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): NCT00253344


Locations
United States, Ohio
Ireland Cancer Center at University Hosptials 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
Study Chair: Matthew M. Cooney, MD Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
  More Information

Publications:
Responsible Party: Matthew Cooney, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00253344     History of Changes
Other Study ID Numbers: CASE2Y04
P30CA043703 ( U.S. NIH Grant/Contract )
CASE2Y04 ( Other Identifier: Case Comprehensive Cancer Center )
AVENTIS-CASE-2Y04
CELGENE-CASE-2Y04
First Submitted: November 11, 2005
First Posted: November 15, 2005
Last Update Posted: June 11, 2010
Last Verified: June 2010

Keywords provided by Case Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific

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