Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00074867
Other study ID # A3521003
Secondary ID
Status Completed
Phase Phase 2
First received December 22, 2003
Last updated November 6, 2006
Start date October 2003
Est. completion date September 2004

Study information

Verified date July 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date September 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

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


Intervention

Drug:
CP-547,632


Locations

Country Name City State
Canada Pfizer Investigational Site Hamilton Ontario
Canada Pfizer Investigational Site Quebec
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Secondary Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Active, not recruiting NCT03648489 - Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma) Phase 2
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT02569983 - The SOCQER-2 Study Surgery in Ovarian Cancer - Quality of Life Evaluation Research
Withdrawn NCT02243059 - Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer Phase 4
Terminated NCT02055690 - PAZOFOS: Phase Ib and Phase II Trial of Pazopanib +/- Fosbretabulin in Advanced Recurrent Ovarian Cancer Phase 1/Phase 2
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Completed NCT00243685 - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis Phase 2/Phase 3
Completed NCT00415181 - Pharmacogenomics of Paclitaxel in Ovarian Cancer N/A
Recruiting NCT01789229 - Establishment of a Tumor Bank for Tissue Samples
Completed NCT00069160 - Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer Phase 2
Completed NCT00772863 - Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer Phase 2
Completed NCT00046800 - Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer Phase 2
Completed NCT00035100 - EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer Phase 2
Terminated NCT00034372 - Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma Phase 2
Completed NCT00001272 - A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients Phase 1
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Recruiting NCT05001282 - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα) Phase 1/Phase 2
Completed NCT02227654 - Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors N/A
Not yet recruiting NCT04055038 - Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC) Phase 2/Phase 3