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| Sponsor: | Princess Margaret Hospital, Canada |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072267 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: 7-hydroxystaurosporine Drug: topotecan hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer |
| Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a 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 up to 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
Tumor lesions accessible for biopsy
No more than 2 prior chemotherapy regimens
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No insulin-dependent diabetes mellitus
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| 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 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: | Hal W. Hirte, MD, FRCP(C) | Margaret and Charles Juravinski Cancer Centre |
More Information
| Study ID Numbers: | CDR0000339563, PMH-PHL-019, NCI-6402 |
| Study First Received: | November 4, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00072267 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer stage III ovarian epithelial cancer |
|
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 |