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Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer

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NCT00074867

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, 90095 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00074867
Pfizer
Completed
Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer

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Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer
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
The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer for patients who have failed first line platinum-based therapy and have a persistent rising CA-125.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
Drug: CP-547,632
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
September 2004
Not Provided

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 â?¥40 U/ml on two separate consecutive determinations made â?¥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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00074867
A3521003
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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