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Sponsored by: |
Beth Israel Deaconess Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00055614 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: topotecan hydrochloride Procedure: adjuvant therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum) |
Estimated Enrollment: | 20 |
Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression.
Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the patients.
Patients are followed every 2 months for at least 6 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer
Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Study Chair: | Stephen A. Cannistra, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | CDR0000269138, BIDMC-E-010405FB, NEDH-E-010405FB |
Study First Received: | March 6, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00055614 History of Changes |
Health Authority: | United States: Federal Government |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Fallopian Tube Cancer Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Adjuvants, Immunologic Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms |
Fallopian Tube Neoplasms Fallopian Tube Diseases Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Topotecan Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Pharmacologic Actions |
Fallopian Tube Neoplasms Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Therapeutic Uses Peritoneal Diseases Peritoneal Neoplasms Topotecan Endocrine Gland Neoplasms |