Carboplatin and Paclitaxel With or Without Bevacizumab Compared to Docetaxel, Carboplatin, and Paclitaxel in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer)
A Phase I Trial of Intravenous Paclitaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Docetaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Paclitaxel, Intraperitoneal Carboplatin, Intraperitoneal Paclitaxel and CTEP-Supplied Agent Bevacizumab (NSC 704865, IND 7921) in Patients With Previously Untreated Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
3 other identifiers
interventional
40
1 country
16
Brief Summary
This phase I trial is studying the side effects and best dose of intraperitoneal infusions of carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel followed by intraperitoneal paclitaxel in treating patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma (cancer). Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 10, 2004
CompletedFirst Posted
Study publicly available on registry
June 11, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedJuly 22, 2019
July 1, 2019
7 years
June 10, 2004
July 19, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum tolerated dose (MTD) of IV paclitaxel with IP carboplatin followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
3 weeks
MTD of IV docetaxel with IP carboplatin followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0
3 weeks
MTD of IV paclitaxel with IP carboplatin and IV bevacizumab followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0
3 weeks
Secondary Outcomes (3)
Incidence of adverse events in patients given IV paclitaxel with IP carboplatin followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0
12 weeks
Incidence of adverse events in patients given of IV docetaxel with IP carboplatin followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0
12 weeks
Incidence of adverse events in patients given IV paclitaxel with IP carboplatin and IV bevacizumab followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0
12 weeks
Study Arms (1)
Treatment (carboplatin, paclitaxel, docetaxel, bevacizumab)
EXPERIMENTALPatients receive IP carboplatin on day 1, and paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B) on day 1, and IP paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive IP carboplatin on day 1, paclitaxel IV on day 1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase. Beginning in course 2 and all subsequent courses, patients receive IP carboplatin on day 1, IV paclitaxel on day 1, and IP paclitaxel on day 8 as in the dose-escalation phase, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given intraperitoneally
Given IV or intraperitoneally
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Histologically confirmed fallopian tube, ovarian epithelial, or primary peritoneal carcinoma
- Stage II-IV disease
- The following epithelial cell types are allowed:
- Carcinosarcoma
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell carcinoma
- Malignant Brenner's tumor
- Adenocarcinoma not otherwise specified
- Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past 12 weeks
- Optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery
- +53 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- Gynecologic Oncology Groupcollaborator
Study Sites (16)
University of California Medical Center At Irvine-Orange Campus
Orange, California, 92868, United States
Colorado Gynecologic Oncology Group
Aurora, Colorado, 80010, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Johns Hopkins University
Baltimore, Maryland, 21287-8936, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104, United States
Cancer Care Associates-Yale
Tulsa, Oklahoma, 74136-1929, United States
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan Walker
Gynecologic Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2004
First Posted
June 11, 2004
Study Start
May 1, 2004
Primary Completion
May 1, 2011
Last Updated
July 22, 2019
Record last verified: 2019-07