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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045175 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: 7-hydroxystaurosporine Drug: topotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors |
Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of UCN-01 and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 12 additional ovarian epithelial cancer patients are then treated at the recommended phase II dose.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 6-10 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have had no more than 2 prior chemotherapy regimens
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Canada, Ontario | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Margaret and Charles Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Study Chair: | Hal W. Hirte, MD, FRCP(C) | Margaret and Charles Juravinski Cancer Centre |
Study ID Numbers: | CDR0000256917, PMH-PHL-005, NCI-5518 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045175 History of Changes |
Health Authority: | United States: Federal Government |
peritoneal cavity cancer recurrent ovarian epithelial cancer fallopian tube cancer |
Fallopian Tube Cancer Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Protein Kinase Inhibitors Genital Diseases, Female Peritoneal Diseases Staurosporine Ovarian Cancer Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases 7-hydroxystaurosporine Abdominal Neoplasms Ovarian Epithelial Cancer Recurrence Fallopian Tube Neoplasms Fallopian Tube Diseases Digestive System Diseases Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Topotecan |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Protein Kinase Inhibitors Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Staurosporine Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors 7-hydroxystaurosporine Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Peritoneal Neoplasms Topotecan |