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

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ClinicalTrials.gov Identifier: NCT00003413
Recruitment Status : Completed
First Posted : August 3, 2004
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
University of Maryland Greenebaum Cancer Center
Information provided by:
University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE August 3, 2004
Last Update Posted Date October 17, 2019
Study Start Date  ICMJE September 1998
Actual Primary Completion Date February 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Official Title  ICMJE 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
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Biological: filgrastim
  • Drug: carmustine
  • Drug: cisplatin
  • Drug: melphalan
  • Drug: paclitaxel
  • Procedure: peripheral blood stem cell transplantation
  • Procedure: surgical procedure
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April¬†9,¬†2007)
32
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2001
Actual Primary Completion Date February 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003413
Other Study ID Numbers  ICMJE CDR0000066426
MSGCC-9749
NCI-V98-1452
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UM Greenebaum Cancer Center
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE University of Maryland Greenebaum Cancer Center
Investigators  ICMJE
Study Chair: Sandra E. Brooks, MD University of Maryland Greenebaum Cancer Center
PRS Account University of Maryland, Baltimore
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP