Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors

NCT00253344 | Completed Phase 1 DMC

• 4 other identifiers: CASE2Y04P30CA043703AVENTIS-CASE-2Y04CELGENE-CASE-2Y04
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  measured at end of phase I

• Dose-limiting toxicity

  measured after every course

Secondary Outcomes (1)

• Disease response

  measured after every 2 courses

Interventions

docetaxel DRUG

Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.

lenalidomide DRUG

Oral lenalidomide on days 1-14. Courses repeat every 21 days until disease progression or unacceptable toxicity.

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

• Sanborn SL, Gibbons J, Krishnamurthi S, Brell JM, Dowlati A, Bokar JA, Nock C, Horvath N, Bako J, Remick SC, Cooney MM. Phase I trial of docetaxel given every 3 weeks and daily lenalidomide in patients with advanced solid tumors. Invest New Drugs. 2009 Oct;27(5):453-60. doi: 10.1007/s10637-008-9200-x. Epub 2008 Nov 15.

  PMID: 19011760 RESULT

MeSH Terms

Interventions

Docetaxel; Lenalidomide

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 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

• Matthew M. Cooney, MD

  Ireland Cancer Center at University Hosptials Case Medical Center, 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: November 11, 2005
• First Posted: November 15, 2005
• Study Start: June 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)