Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01183663
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    Starting dose 10 mg by mouth daily for 21 days of a 28 day cycle.
  • Bevacizumab — DRUG
    Starting dose: 5 mg/kg by vein every 2 weeks of a 28 day cycle.
  • Sorafenib — DRUG
    Starting dose: 200 mg by mouth daily for 28 a day cycle.
  • Temsirolimus — DRUG
    Starting dose: 15 mg by vein every week for a 28 day cycle.
  • Lenalidomide — DRUG
    Starting dose: 5 mg by mouth daily for 14 days of a 21 day cycle.
  • Oxaliplatin — DRUG
    Starting dose: 65 mg/m2 by vein on day 1 of a 21 day cycle.
  • Leucovorin — DRUG
    400 mg/m2 by vein on day 1 of a 21 day cycle.
  • 5-fluorouracil — DRUG
    400 mg/m2 by vein through ambulatory pump on days 1-2 of a 21 day cycle.

Study Details

The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.

Key Dates

First listed
Aug 17, 2010
Start date
Aug 31, 2010
Status verified
Jun 2016
Primary completion
May 31, 2016
Completion
May 31, 2016

Study Design

Enrollment
180 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenalidomide + Bevacizumab
    Lenalidomide starting dose: 10 mg by mouth daily for 21 days of a 28 day cycle. Bevacizumab starting dose: 5 mg/kg by vein every 2 weeks of a 28 day cycle.
  • Experimental: Lenalidomide + Sorafenib
    Lenalidomide starting dose: 10 mg by mouth daily for 21 days of a 28 day cycle. Sorafenib starting dose: 200 mg by mouth daily for 28 a day cycle.
  • Experimental: Lenalidomide + Temsirolimus
    Lenalidomide starting dose: 10 mg by mouth daily for 21 days of a 28 day cycle. Temsirolimus starting dose: 15 mg by vein every week for a 28 day cycle.
  • Experimental: Lenalidomide + Oxaliplatin + Leucovorin + 5-fluorouracil
    Lenalidomide starting dose: 5 mg by mouth daily for 14 days of a 21 day cycle. Oxaliplatin starting dose: 65 mg/m2 by vein on day 1 of a 21 day cycle. Leucovorin 400 mg/m2 by vein on day 1 of a 21 day cycle. 5-fluorouracil 400 mg/m2 by vein through ambulatory pump on days 1-2 of a 21 day cycle.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX) [ Time Frame: First 21/28 day cycle ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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