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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian 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: NCT00003297
Recruitment Status : Completed
First Posted : July 8, 2004
Last Update Posted : March 24, 2011
National Cancer Institute (NCI)
Information provided by:
Georgetown University

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: mitoxantrone hydrochloride Drug: thiotepa Drug: topotecan hydrochloride Procedure: peripheral blood stem cell transplantation Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Primary Purpose: Treatment
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 Start Date : December 1997
Primary Completion Date : January 2001
Study Completion Date : January 2001

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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): NCT00003297

United States, District of Columbia
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
National Cancer Institute (NCI)
Study Chair: Gary Spitzer, MD Lombardi Comprehensive Cancer Center

Responsible Party: John Marshall, MD, Georgetown University Identifier: NCT00003297     History of Changes
Other Study ID Numbers: CDR0000066235
P30CA051008 ( U.S. NIH Grant/Contract )
First Posted: July 8, 2004    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: September 2000

Keywords provided by Georgetown University:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors