Lenalidomide, Docetaxel, and Carboplatin in Treating Patients With Advanced Solid Tumors

NCT00415116 | Completed Phase 1

• 2 other identifiers: CASE-CCF-7216P30CA043703
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 and carboplatin 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 and carboplatin in treating patients with advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose of lenalidomide

• Dose-limiting toxicity of lenalidomide

Secondary Outcomes (2)

• Safety and toxicity

• Clinical activity

Interventions

carboplatin DRUG

docetaxel DRUG

lenalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically proven solid tumor * Measurable or evaluable disease * Refractory to standard treatment * No prior failure of a docetaxel and carboplatin regimen except in the adjuvant setting * History of brain disease allowed, provided the following criteria are met: * Brain disease previously treated with radiotherapy or surgery * Asymptomatic with no active brain disease, as documented by CT scan or MRI, for at least 3 months PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 1.5 mg/dL * Bilirubin normal * AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present) * Alkaline phosphatase ≤ 3 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment * No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent, expose the patient to unacceptable risk, or affect the interpretation of study data * No known hypersensitivity to thalidomide * No history of erythema nodosum, characterized by a desquamating rash, while taking thalidomide or similar drugs * No pre-existing peripheral neuropathy ≥ grade 2 * No known hypersensitivity or intolerance to taxanes * No known HIV positivity * No known infectious hepatitis, types A, B, or C PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 2 prior chemotherapy regimens * At least 28 days since prior cancer therapy, including radiotherapy, biologic therapy, hormonal therapy, chemotherapy, or surgery * At least 28 days since any other prior investigational drug or therapy * No prior lenalidomide * No other concurrent chemotherapy or biologic therapy * No concurrent radiotherapy * No concurrent use of any other anticancer agents or treatments * No prophylactic granulocyte colony-stimulating factors (G-CSF) during the first course of study treatment * No concurrent prophylactic antibiotics * No concurrent treatment with the following medications: * Systemic corticosteroids (except as prophylaxis for docetaxel administration) * Estrogens * Azoles * Macrolides * Cyclosporine * Rifampin * Phenytoin

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Interventions

Carboplatin; Docetaxel; Lenalidomide

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tarek M. Mekhail, MD

  Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: August 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: July 8, 2011

Record last verified: 2006-11