Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

NCT00511992 | Completed Phase 2 Results DMC

• 1 other identifier: 2674
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Ovarian Carcinoma; Primary Peritoneal Carcinoma; Ovarian Carcinosarcoma

Keywords

Ovarian Cancer; Gynecologic Cancer; Ovarian Carcinoma; Peritoneal Carcinoma; IP chemotherapy; Intraperitoneal; Avastin; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Number of Patients Able to Complete 6 Cycles of Treatment.

  Completion of cycle 6

  2 years

Secondary Outcomes (1)

• Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.

  2 years

Study Arms (1)

Avastin

EXPERIMENTAL

Drug: Avastin; Drug: Paclitaxel; Drug: Cisplatin

Interventions

Avastin DRUG

Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles

Also known as: Bevacizumab

Avastin

Paclitaxel DRUG

Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles

Avastin

Cisplatin DRUG

75mg/m2 IP day 2 every 21 days x 6 cycles

Avastin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Ingrid Block, CTO Director
• Organization: University of Oklahoma

ingrid-block@ouhsc.edu

405 271-8001

Study Officials

• D. Scott McMeekin, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 6, 2007
• Study Start: July 1, 2007
• Primary Completion: August 3, 2015
• Study Completion: August 3, 2015
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-06

Locations

US (1)