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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00053365 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: irofulven |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Evaluation Of Irofulven (IND #55804, NSC #683863) In The Treatment Of Recurrent Or Persistent Platinium-Sensitive Ovarian Or Primary Peritoneal Cancer |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2003 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Patients are followed at approximately 30 days, every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within at least 6 months.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
At least 1 unidimensionally measurable target lesion* defined as:
Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease
Platinum-sensitive disease
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 57 Study Locations| Study Chair: | Russell J. Schilder, MD | Fox Chase Cancer Center |
More Information
| Study ID Numbers: | CDR0000269484, GOG-0146O |
| Study First Received: | January 27, 2003 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00053365 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 Peritoneal Diseases Irofulven Ovarian Cancer Gastrointestinal Neoplasms Antineoplastic Agents, Alkylating Endocrinopathy Peritoneal Neoplasms Alkylating Agents Endocrine Gland Neoplasms |
|
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms |
Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Abdominal Neoplasms Pharmacologic Actions Adnexal Diseases Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Irofulven Peritoneal Neoplasms Antineoplastic Agents, Alkylating |