Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer

October 15, 2019 updated by: University of Maryland, Baltimore

High Dose Chemotherapy With Stem Cell Rescue in Recently Diagnosed Patients With Advanced (Stage III and IV) Ovarian Cancer With > 1 cm Residual Disease After Debulking Surgery

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian epithelial cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Evaluate the complete response rates, event free survival, and overall survival of patients with recently diagnosed stage III or IV ovarian epithelial cancer receiving carmustine plus melphalan followed by consolidation therapy after having undergone surgical debulking. II. Evaluate the therapy related mortality associated with the autotransplant and the consolidation therapy in these patients. III. Evaluate the quality of life in this patient population.

OUTLINE: Patients are stratified by stage (III vs IV) and volume of residual disease (less than 3 cm vs at least 3 cm). Approximately 10-15 days after surgery, patients receive filgrastim (G-CSF) subcutaneously daily until all peripheral blood stem cell (PBSC) collections have been completed. Patients then receive carmustine IV over 2 hours on day -2 and melphalan IV over 20 minutes on day -1. Peripheral blood stem cells are infused 24 hours after melphalan on day 0. Patients receive G-CSF subcutaneously beginning on day 6 and continuing until granulocytes have recovered. Three months after the PBSC infusion, patients receive consolidation therapy with paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3. Consolidation treatment is repeated every 3 months for a total of 4 courses. Quality of life questionnaires are completed prior to PBSC transplant, before discharge after transplant, before each consolidation treatment, and 3 months after the last consolidation course. Patients are followed at least every 3 months for the first 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: An estimated 32 patients will be accrued into this study over 3-4 years.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial cancer who have undergone surgical debulking Stage III patients must have greater than 1 cm residual mass after surgery Must have had no more than 1 course of platinum based chemotherapy No CNS disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: LVEF at least 50% Pulmonary: FVC, FEV1, and corrected DLCO at least 50% of predicted If unable to complete pulmonary function tests due to pain related to the recent surgery, patient must have a high resolution CT scan of the chest and acceptable arterial blood gases (PO2 at least 70) Other: HIV negative No active infection requiring intravenous antibiotics Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

University of Maryland Greenebaum Cancer Center

Investigators

  • Study Chair: Sandra E. Brooks, MD, University of Maryland Greenebaum Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Primary Completion (Actual)

February 1, 2001

Study Completion (Actual)

February 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 2, 2004

First Posted (Estimate)

August 3, 2004

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066426
  • MSGCC-9749
  • NCI-V98-1452

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on cisplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe