VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00436501
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Fallopian Tube Cancer
  • Malignant Tumor of Peritoneum
  • Recurrent Ovarian Epithelial Cancer

Eligibility Criteria

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

Interventions

  • docetaxel — DRUG
    25 mg/m\^2 given intravenously (IV) over 1 hour (+/- 10 minutes) following VEGF Trap every 3 weeks starting cycle 1 (21 day cycles)
  • ziv-aflibercept — BIOLOGICAL
    Starting dose 2 mg/kg given IV Cycle 0. Phase I Group: Every 3 weeks beginning with Cycle 0 (Completed 03/14/2008); Phase II Group: Every 3 weeks starting cycle 1 (Opened 05/09/2008).
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

This phase I/II trial is studying the side effects and best dose of VEGF Trap when given together with docetaxel and to see how well they work in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. VEGF Trap 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 VEGF Trap together with docetaxel may kill more tumor cells

Key Dates

Start date
Jan 31, 2007
Status verified
Feb 2019
Primary completion
Mar 31, 2011
Completion
Nov 30, 2012

Study Design

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

Arms

  • Experimental: Treatment (VEGF Trap, Docetaxel)
    Phase I (closed to accrual as of 3/14/2008): Patients receive VEGF Trap IV over 1 hour on day 1 of course 1. Patients then receive VEGF Trap IV over 1 hour and docetaxel IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of VEGF Trap until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 or 6 patients experience dose-limiting toxicity.
  • Experimental: Phase II Treatment (VEGF Trap, Docetaxel)
    Phase II (opened to accrual as of 5/9/2008): Patients receive VEGF Trap at the MTD determined in phase I and docetaxel as in phase I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose of VEGF Trap (Phase I) [ Time Frame: 21 day cycle, up to 3 cycles ]

Locations (2)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-
University of Virginia Health SystemCharlottesvilleVirginia22903-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TXUniversity of Virginia Health System· Charlottesville, VA

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