Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003413
Recruitment Status : Completed
First Posted : August 3, 2004
Last Update Posted : October 17, 2019
University of Maryland Greenebaum Cancer Center
Information provided by:
University of Maryland, Baltimore

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Biological: filgrastim Drug: carmustine Drug: cisplatin Drug: melphalan Drug: paclitaxel Procedure: peripheral blood stem cell transplantation Procedure: surgical procedure Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 1998
Actual Primary Completion Date : February 2001
Actual Study Completion Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003413

Layout table for location information
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
University of Maryland Greenebaum Cancer Center
Layout table for investigator information
Study Chair: Sandra E. Brooks, MD University of Maryland Greenebaum Cancer Center

Layout table for additonal information
Responsible Party: UM Greenebaum Cancer Center Identifier: NCT00003413     History of Changes
Other Study ID Numbers: CDR0000066426
First Posted: August 3, 2004    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Keywords provided by University of Maryland, Baltimore:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs