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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mitoxantrone hydrochloride
thiotepa
topotecan hydrochloride
peripheral blood stem cell transplantation
Sponsored by
Georgetown University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV epithelial ovarian cancer that is refractory to platinum therapy or has relapsed within 12 months after platinum therapy Minimal residual disease by laparotomy Must have adequate number of peripheral stem cells collected No intraabdominal, pelvic disease, or other disease greater than 1 cm No brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2 times the upper limit of normal (ULN) Serum transaminases less than 2 times ULN Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: Cardiac ejection fraction at least 45% No active angina No uncontrolled hypertension Pulmonary: FEV1, vital capacity, and diffusion capacity greater than 50% of predicted Other: Not HIV positive No active hepatitis B or C infection Not pregnant No concurrent malignancy except basal cell or squamous cell carcinoma of the skin No serious medical conditions such as uncontrolled diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: No immunotherapy within the past 4 weeks No concurrent immunotherapy Chemotherapy: No chemotherapy within the past 4 weeks No mitomycin within the past 6 weeks No other concurrent chemotherapy No prior anthracycline therapy greater than 200 mg/m2 Endocrine therapy: Not specified Radiotherapy: No radiotherapy within the past 4 weeks No concurrent radiotherapy No prior radiotherapy to the whole abdomen Surgery: Prior surgery allowed

Sites / Locations

  • Vincent T. Lombardi Cancer Research Center, Georgetown University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 22, 2011
Sponsor
Georgetown University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003297
Brief Title
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian Cancer
Official Title
Phase I/II Study of High Dose Topotecan, Mitoxantrone and Thiotepa (TMT) Followed by Autologous Stem Cell Transplant in Patients With Recurrent Platinum Resistant Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2000
Overall Recruitment Status
Completed
Study Start Date
December 1997 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
January 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Georgetown University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian cancer that has not recurred or that has not responded to previous chemotherapy.
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicities of topotecan, mitoxantrone, and thiotepa given in combination followed by autologous peripheral blood stem cell transplantation in patients with recurrent or refractory platinum resistant epithelial ovarian cancer. II. Determine the progression-free survival and overall survival of these patients after this therapy. OUTLINE: This is a dose escalation study of topotecan. All patients have peripheral stem cells collected. Patients then receive topotecan according to an escalating dose schedule, and mitoxantrone and thiotepa on a fixed dose schedule. Patients receive topotecan by continuous infusion for 24 hours on days 1-3, mitoxantrone intravenously over 1 hour on days 1-3, and thiotepa intravenously over 4 hours on days 1-3, followed 48 hours later by infusion of their peripheral stem cells. Patients may receive a second course of chemotherapy and peripheral stem cell transplantation in the absence of disease progression and unacceptable toxicity. Dose escalation of topotecan continues in cohorts of 3-6 patients each 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 week for the first month, then every month for 6 months, every 3 months for 1 year, and then every 6 months. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Type
Drug
Intervention Name(s)
thiotepa
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV epithelial ovarian cancer that is refractory to platinum therapy or has relapsed within 12 months after platinum therapy Minimal residual disease by laparotomy Must have adequate number of peripheral stem cells collected No intraabdominal, pelvic disease, or other disease greater than 1 cm No brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2 times the upper limit of normal (ULN) Serum transaminases less than 2 times ULN Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: Cardiac ejection fraction at least 45% No active angina No uncontrolled hypertension Pulmonary: FEV1, vital capacity, and diffusion capacity greater than 50% of predicted Other: Not HIV positive No active hepatitis B or C infection Not pregnant No concurrent malignancy except basal cell or squamous cell carcinoma of the skin No serious medical conditions such as uncontrolled diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: No immunotherapy within the past 4 weeks No concurrent immunotherapy Chemotherapy: No chemotherapy within the past 4 weeks No mitomycin within the past 6 weeks No other concurrent chemotherapy No prior anthracycline therapy greater than 200 mg/m2 Endocrine therapy: Not specified Radiotherapy: No radiotherapy within the past 4 weeks No concurrent radiotherapy No prior radiotherapy to the whole abdomen Surgery: Prior surgery allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Spitzer, MD
Organizational Affiliation
Lombardi Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vincent T. Lombardi Cancer Research Center, Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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