Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer

January 3, 2014 updated by: Herbert Irving Comprehensive Cancer Center

Phase I-II Study of Tandem Cycles of High Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Support in Women With Persistent, Refractory or Recurrent Advanced (Stage III or IV), Epithelial Ovarian Cancer

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

PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and autologous peripheral stem cell transplantation in treating patients with recurrent or persistent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of topotecan with a fixed dose of etoposide phosphate as a component of a multicourse high dose chemotherapy regimen supported by peripheral blood stem cell transplantation in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
  • Evaluate the response, time to progression, disease free survival, and overall survival in this patient population.

OUTLINE: This is a dose escalation study of topotecan.

All patients receive induction therapy consisting of 1 to 2 courses of mobilization therapy. Subcutaneous filgrastim (G-CSF) is given beginning 24 hours after induction dose. Following induction therapy, peripheral blood stem cells (PBSC) are harvested. After patients receive high dose paclitaxel and carboplatin chemotherapy, a portion of the PBSC are reinfused. When patients recover from the paclitaxel/carboplatin chemotherapy the administration of topotecan and etoposide phosphate begins. Topotecan is administered, as a 72 hour continuous infusion, according to a dose escalation schedule with a fixed dose of etoposide phosphate. A second portion of PBSC are reinfused after topotecan/etoposide phosphate chemotherapy. A course of thiotepa is given along with the final portion of PBSC after treatment with topotecan and etoposide phosphate.

Dose escalation of topotecan continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity.

Patients are followed every 3 months for 1 year and every 4 months thereafter to determine progression free and overall survival.

PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for the phase I portion of this study, and 25 more patients will be accrued for the phase II portion.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

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
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically proven persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer following at least 3 courses of initial standard platinum based chemotherapy OR have radiologic evidence of recurrence with a CA125 greater than 100
  • Initial stage IV disease having a complete response following platinum based therapy allowed
  • No brain metastases
  • Not eligible for other high priority national or institutional study

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Greater than 2 months

Hematopoietic:

  • WBC greater than 3000/mm3
  • Absolute neutrophil count greater than 1500/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • Bilirubin less than 1.5 times normal
  • SGOT or SGPT less than 1.5 times normal
  • PT/PTT within normal limits

Renal:

  • BUN less than 1.5 times normal
  • Creatinine less than 1.5 times normal
  • Creatinine clearance greater than 55 mL/min

Cardiovascular:

  • LVEF at least 45%

Other:

  • Not pregnant or nursing
  • HIV negative
  • No prior malignancy other than curatively treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or breast cancer if the risk of recurrence is sufficiently low
  • No serious illness that would prevent treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 weeks since prior radiotherapy

Surgery:

  • Not specified

Other:

  • No concurrent acetaminophen

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

Herbert Irving Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Amy D. Tiersten, MD, Herbert Irving Comprehensive 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

January 1, 1997

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 17, 2003

First Posted (Estimate)

April 18, 2003

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

December 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065734
  • CPMC-IRB-7866
  • NCI-G97-1327

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.

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