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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020696 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining tirapazamine with cisplatin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: cisplatin Drug: tirapazamine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Evaluation of Tirapazamine (NSC #130181, IND #46,525) in Combination With Cisplatin in Recurrent Platinum Sensitive Ovarian or Primary Peritoneal Cancer |
| Study Start Date: | June 2001 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive tirapazamine IV over 2 hours followed 1 hour later by cisplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 1 unidimensionally measurable lesion
Platinum-sensitive disease
One prior chemotherapy regimen containing cisplatin or another platinum compound for primary disease required
Ineligible for a higher priority GOG protocol (any active GOG phase III protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 54 Study Locations| Study Chair: | Allan Covens, MD | Edmond Odette Cancer Centre at Sunnybrook |
More Information
| Study ID Numbers: | CDR0000068705, GOG-0146M |
| Study First Received: | July 11, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00020696 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer peritoneal cavity cancer |
|
Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Recurrence Genital Diseases, Female |
Digestive System Diseases Radiation-Sensitizing Agents Cisplatin Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Tirapazamine Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
|
Digestive System Neoplasms Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Pharmacologic Actions Adnexal Diseases |
Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Peritoneal Diseases Tirapazamine Peritoneal Neoplasms Endocrine Gland Neoplasms |