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Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

University of Oklahoma (OU) logo

University of Oklahoma (OU)

Status and phase

Completed
Phase 2

Conditions

Advanced Ovarian Carcinoma
Ovarian Carcinosarcoma
Primary Peritoneal Carcinoma

Treatments

Drug: Paclitaxel
Drug: Avastin
Drug: Cisplatin

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.

Full description

Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.

Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.

Enrollment

20 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma.
  • Adequate bone marrow, renal, and hepatic function
  • Patients must be entered no more than twelve weeks postoperatively

Exclusion criteria

  • Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
  • Stage IV or suboptimally debulked disease following primary cytoreductive surgery
  • Patients who have received prior radiotherapy or chemotherapy.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Avastin
Experimental group
Treatment:
Drug: Paclitaxel
Drug: Avastin
Drug: Cisplatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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