NCT00127920

Brief Summary

The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy (Morrow \& Curtin, 1998). This involves an optimal primary tumor debulking surgery. The most active chemotherapy agents should then be promptly administered. Taxol and Carboplatin or Cisplatin have become the standard" first line" therapy because of proven survival benefits with those regimens in treating advanced ovarian adenocarcinoma patients. New chemotherapy agents like bevacizumab have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients and are being studied for their potential contributory impact on the current standard of treatment. Since no triplet regimen has demonstrated compelling superiority, the combination of taxol, carboplatin, and bevacizumab is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity. The null hypothesis (Ho) is that the drug regimen will demonstrate an 80% patient response rate (RR). The alternative Hypothesis (H1): The triplet drug regimen will demonstrate a significantly higher patient response rate than standard therapy. Hypothesis (H2): The triplet drug regimen will demonstrate a significantly more favorable patient time to tumor progression rate than standard therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 5, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

August 5, 2005

Last Update Submit

March 9, 2015

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (2)

  • time to tumor progression

  • response rate

Secondary Outcomes (2)

  • safety

  • survival

Study Arms (1)

Single Arm

EXPERIMENTAL

Paclitaxel, Carboplatin and Avastin on day1 every 21 days

Drug: Avastin

Interventions

AvastinDRUG

Paclitaxel, Carboplatin and Avastin given on day 1 every 21 days

Also known as: Bevacizumab
Single Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.
  • Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.
  • If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.
  • Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC \> 3,000 cells/cu ml., platelets \> 100,000/cu.ml., calculated creatinine clearance \> 50 ccs/min., bilirubin \< 1.5 mg/dl, and SGOT \< three times normal.
  • Karnofsky performance status \> 50%.
  • Subjects who have signed an institutional review board (IRB) approved informed consent form.

You may not qualify if:

  • Subjects with epithelial ovarian cancer of low malignancy potential.
  • Subjects with septicemia, severe infection, or acute hepatitis.
  • Subjects with severe gastrointestinal bleeding.
  • Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

Location

Florida Hospital College of Health Sciences

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • John P Micha, MD

    Gynecologic Oncology Associates

    PRINCIPAL INVESTIGATOR

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 5, 2005

First Posted

August 9, 2005

Study Start

August 1, 2004

Primary Completion

August 1, 2006

Study Completion

October 1, 2012

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

US(2)