NCT00079430

Brief Summary

This phase I trial is studying the side effects and best dose of adjuvant intraperitoneal carboplatin when given together with paclitaxel and bevacizumab in treating patients who have undergone debulking surgery for stage II , stage III, or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin and paclitaxel in treating ovarian epithelial or primary peritoneal cancer, or fallopian tube cancer.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P75+ for phase_1

Geographic Reach
2 countries

19 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

First Submitted

Initial submission to the registry

March 8, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2004

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

6.9 years

First QC Date

March 8, 2004

Last Update Submit

July 19, 2019

Conditions

Brenner TumorFallopian Tube CancerOvarian Clear Cell CystadenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Mixed Epithelial CarcinomaOvarian Mucinous CystadenocarcinomaOvarian Serous CystadenocarcinomaOvarian Undifferentiated AdenocarcinomaPrimary Peritoneal Cavity CancerStage II Ovarian Epithelial CancerStage III Ovarian Epithelial CancerStage IV Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose (MTD) of intraperitoneal carboplatin with intravenous paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

    3 weeks

  • Incidence of adverse events in patients given intraperitoneal carboplatin with intravenous paclitaxel at the MTD, assessed by CTCAE v3.0

    12 weeks

  • Number of observed DLTs in patients given intraperitoneal carboplatin with intravenous paclitaxel and intravenous bevacizumab, graded using CTCAE v3.0

    6 weeks

Secondary Outcomes (3)

  • Incidence of adverse events in patients given intraperitoneal carboplatin with intravenous paclitaxel and intravenous bevacizumab, graded using CTCAE v3.0

    12 weeks

  • Response rate (in patients with measurable disease who are in the expanded cohort) assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

    Up to 1 year

  • Progression-free survival assessed by RECIST

    From study entry until disease progression, death or date of last contact, up to 1 year

Study Arms (1)

Treatment (adjuvant, paclitaxel, carboplatin, bevacizumab)

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Procedure: adjuvant therapyDrug: paclitaxelDrug: carboplatinBiological: bevacizumab

Interventions

adjuvant therapyPROCEDURE
Treatment (adjuvant, paclitaxel, carboplatin, bevacizumab)
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Treatment (adjuvant, paclitaxel, carboplatin, bevacizumab)
carboplatinDRUG

Given intraperitoneally

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Treatment (adjuvant, paclitaxel, carboplatin, bevacizumab)
bevacizumabBIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Treatment (adjuvant, paclitaxel, carboplatin, bevacizumab)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Stage II-IV disease
  • The following histologic epithelial cell types are eligible:
  • Serous adenocarcinoma
  • Mucinous adenocarcinoma
  • Clear cell adenocarcinoma
  • Transitional cell carcinoma
  • Adenocarcinoma not otherwise specified
  • Endometrioid adenocarcinoma
  • Undifferentiated carcinoma
  • Mixed epithelial carcinoma
  • Malignant Brenner's tumor
  • Optimal (≤ 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks)
  • Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true:
  • Stage IB disease or less
  • +52 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

University of California Medical Center At Irvine-Orange Campus

Orange, California, 92868, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Cancer Care Associates-Midtown

Tulsa, Oklahoma, 74104, United States

Location

Tulsa Cancer Institute

Tulsa, Oklahoma, 74146, United States

Location

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Pacific Gynecology Specialists

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Kawasaki Medical School

Okayama-Ken, Kurashiki, 701-0192, Japan

Location

Saitama Medical University International Medical Center

Saitama, 350-1298, Japan

Location

MeSH Terms

Conditions

Brenner TumorFallopian Tube NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Chemotherapy, AdjuvantPaclitaxelTaxesCarboplatinBevacizumab

Condition Hierarchy (Ancestors)

Neoplasms, FibroepithelialNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersEndocrine System DiseasesNeoplasms by SiteFallopian Tube DiseasesCarcinomaEndocrine Gland Neoplasms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsCoordination ComplexesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mark Morgan

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

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

March 8, 2004

First Posted

March 10, 2004

Study Start

June 1, 2004

Primary Completion

May 1, 2011

Last Updated

July 22, 2019

Record last verified: 2019-07

Locations

JP(2)US(17)