Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01187199
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • Temsirolimus — DRUG
    Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle.
  • Bevacizumab — DRUG
    Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
  • Paclitaxel — DRUG
    Starting dose 30 mg/m2 given by vein on day 1 of a 21 day cycle.
  • Sorafenib — DRUG
    Starting dose 200 mg by mouth daily for a 21 day cycle.
  • Carboplatin — DRUG
    Starting dose AUC 2 by vein on day 1 of a 21 day cycle.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of the combination of bevacizumab (Avastin) and temsirolimus (Torisel) that can be given with 1 of 3 other study drugs --carboplatin (Paraplatin), paclitaxel (Taxol), or sorafenib (Nexavar). The safety of these drug combinations will also be studied.

Key Dates

First listed
Aug 23, 2010
Start date
Aug 19, 2010
Status verified
Apr 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
278 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin Group
    Carboplatin: Starting dose AUC 2 by vein on day 1 of a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
  • Experimental: Paclitaxel Group
    Paclitaxel: Starting dose 30 mg/m2 given by vein on day 1 of a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
  • Experimental: Sorafenib Group
    Sorafenib: Starting dose 200 mg by mouth daily for a 21 day cycle. Temsirolimus: Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle. Bevacizumab: Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 4 weeks ]

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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