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A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Recurrent Or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, Or Fallopian Tube Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms

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Trial Information

A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Recurrent Or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, Or Fallopian Tube Cancer


Inclusion Criteria:



- Histologically proven epithelial ovarian cancer, primary peritoneal serous cancer, or
fallopian tube cancerRecurrent or persistent elevated CA-125.

- For the purpose of this study, elevated CA-125 is defined as a value of ≥40 U/ml on
two separate consecutive determinations made ≥1 week apart.

- CA-125 values obtained within 4 weeks of abdominal surgery should not be taken into
account.

- No definitive disease or clinical and findings of small volume disease (£1cm by
spiral CT or £2cm by conventional CT or clinical exam).

Exclusion Criteria:

- No prior exposure to mouse antibodies or prior VEGF or VEGF receptor targeted
treatment or other anti-angiogenic-directed, anti-cancer treatment including
thalidomide.

- No prior consolidation therapy with cytotoxic agents for ovarian cancer.

- Continuation of hormone replacement therapy is permitted.

- No requirement for concomitant anticoagulant therapy.

- Administration of low dose anticoagulants for maintenance of central venous access is
permitted.No chronic oral or intravenous steroid use.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

At the completion of Stage 1 of the study, it did not meet the objective response criteria to proceed to Stage 2 of the trial.

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A3521003

NCT ID:

NCT00074867

Start Date:

October 2003

Completion Date:

September 2004

Related Keywords:

  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247