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Phase II Study of Paclitaxel, Intraperitoneal Cisplatin and IV Bevacizumab Followed by Bevacizumab Consolidation for Advanced Ovarian and Peritoneal Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Advanced Ovarian Carcinoma, Primary Peritoneal Carcinoma, Ovarian Carcinosarcoma

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Trial Information

Phase II Study of Paclitaxel, Intraperitoneal Cisplatin and IV Bevacizumab Followed by Bevacizumab Consolidation for Advanced Ovarian and Peritoneal Carcinoma


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluating the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

D. Scott McMeekin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Food and Drug Administration

Study ID:

AVF3953 McMeekin

NCT ID:

NCT00511992

Start Date:

July 2007

Completion Date:

July 2012

Related Keywords:

  • Advanced Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
  • Ovarian Carcinosarcoma
  • Ovarian Cancer
  • Gynecologic Cancer
  • Ovarian Carcinoma
  • Peritoneal Carcinoma
  • IP chemotherapy
  • Intraperitoneal
  • Avastin
  • Bevacizumab
  • Carcinoma
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104