Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00652691 |
RATIONALE: Giving colony-stimulating factors, such as G-CSF help stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Combination chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This randomized trial is studying the side effects and best dose of topotecan when given together with high-dose cyclophosphamide, and carboplatin followed by an autologous peripheral blood stem cell transplant in treating patients with recurrent ovarian cancer or primary peritoneal cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin Drug: cyclophosphamide Drug: filgrastim Drug: topotecan hydrochloride Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Dose Seeking Trial of Topotecan Combined With High-Dose Cyclophosphamide and Carboplatin With Peripheral Blood Stem Cell Transplant for the Treatment of Relapsed Ovarian Cancer and Primary Peritoneal Cancer |
Estimated Enrollment: | 48 |
Study Start Date: | August 1998 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose escalation study of topotecan.
After completion of study therapy, patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 5 years.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
Recurrent, relapsed, or persistent disease meeting 1 or more of the following criteria:
The following histological cell types are allowed:
PATIENT CHARACTERISTICS:
No severe medical or psychiatric illness, including any of the following:
PRIOR CONCURRENT THERAPY:
Study Chair: | Mark R. Litzow, MD | Mayo Clinic |
Investigator: | Prema P. Peethambaram, MD | Mayo Clinic |
Investigator: | Scott H. Kaufmann, MD, PhD | Mayo Clinic |
Investigator: | Lynn C. Hartmann, MD | Mayo Clinic |
Study ID Numbers: | CDR0000582307, MAYO-976101 |
Study First Received: | April 3, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00652691 |
Health Authority: | United States: Federal Government |
peritoneal cavity cancer ovarian clear cell tumor with proliferating activity ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma |
recurrent ovarian epithelial cancer ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma |
Cystadenocarcinoma, Serous Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Cyclophosphamide Ovarian epithelial cancer Carcinoma, Endometrioid Genital Diseases, Female Peritoneal Diseases Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Carboplatin Abdominal Neoplasms Recurrence Carcinoma Digestive System Diseases Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Adenocarcinoma Topotecan |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |