Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors
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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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Maximum tolerated dose [ Time Frame: measured at end of phase I ] [ Designated as safety issue: Yes ]
- Dose-limiting toxicity [ Time Frame: measured after every course ] [ Designated as safety issue: Yes ]
- Disease response [ Time Frame: measured after every 2 courses ] [ Designated as safety issue: No ]
| 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) |
-
Drug: docetaxel
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Ohio | |
| Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | Matthew M. Cooney, MD | Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional 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, CASE2Y04, AVENTIS-CASE-2Y04, CELGENE-CASE-2Y04 |
| Study First Received: | November 11, 2005 |
| Last Updated: | June 10, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Docetaxel Lenalidomide Thalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013