Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01197170
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer
  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Anastrozole — DRUG
    1 mg by mouth daily of a 28 day cycle.
  • Bevacizumab — DRUG
    Starting dose 10 mg by vein on day 1 of a 21 day cycle.
  • Everolimus — DRUG
    Starting dose 5 mg by mouth daily for a 28 day cycle.
  • Sorafenib — DRUG
    Starting dose 200 mg by mouth twice a day of a 28 day cycle.
  • Erlotinib — DRUG
    Starting dose 75 mg by mouth daily for a 28 day cycle.

Study Details

The goal of this clinical research study to find the highest tolerated dose of anastrozole alone or in combination with either everolimus (Afinitor), sorafenib (Nexavar), erlotinib (Tarceva), fulvestrant (Faslodex), or bevacizumab (Avastin) that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied.

Key Dates

Start date
Sep 7, 2010
Status verified
Jan 2021
Primary completion
Jan 13, 2021
Completion
Jan 13, 2021

Study Design

Enrollment
277 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anastrozole
    1 mg PO (by mouth) daily for 28 days.
  • Experimental: Anastrozole + Bevacizumab
    Anastrozole 1 mg PO daily and Bevacizumab starting dose 10 mg IV Day 1 of 21 day cycle. Expansion group added when MTD dose of Anastrozole + Bevacizumab found.
  • Experimental: Anastrozole + Everolimus
    Anastrozole 1 mg PO daily and Everolimus starting dose 5 mg PO daily for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Everolimus found.
  • Experimental: Anastrozole + Sorafenib
    Anastrozole 1 mg PO daily and Sorafenib starting dose 200 mg PO twice a day for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Sorafenib found.
  • Experimental: Anastrozole + Erlotinib
    Anastrozole 1 mg PO daily and Erlotinib starting dose 75 mg PO daily for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Erlotinib found.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 28 day cycle ]

Locations (1)

FacilityCityStateZIP
University of Texas MD Anderson Cancer CenterHoustonTexas77030

Find similar trials in Houston, TX

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

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