Nitrocamptothecin in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
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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 nitrocamptothecin in treating patients who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cavity Cancer |
Drug: rubitecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation Of 9-Nitro-Camptothecin In The Third-Line Treatment Of Recurrent Ovarian Or Primary Peritoneal Cancer |
| Enrollment: | 0 |
OBJECTIVES:
- Determine the antitumor activity of nitrocamptothecin in patients with recurrent or metastatic ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: Patients receive oral nitrocamptothecin on days 1-5. Treatment continues every 7 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks, then every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 22 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer
Measurable disease
- Ascites and pleural effusions are not considered measurable
- Sonography allowed if bidimensionally measurable
- Must not be eligible for higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Granulocyte count at least 1,500/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT and alkaline phosphatase no greater than 3 times ULN
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- No other prior or concurrent invasive malignancy in the past 5 years except nonmelanoma skin cancer
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least but no more than 2 prior chemotherapy regimens containing carboplatin, cisplatin, or another organoplatinum compound combined with paclitaxel
- Second line therapy may include any agents except topoisomerase I inhibitors (i.e., topotecan)
- No prior nitrocamptothecin or topoisomerase I inhibitors
- At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 3 weeks since prior radiotherapy and recovered
Surgery:
- At least 3 weeks since prior surgery and recovered
Other:
- No prior cancer therapy that contraindicates this study
Contacts and Locations
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006267 History of Changes |
| Other Study ID Numbers: | CDR0000068210, GOG-0186B |
| Study First Received: | September 11, 2000 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Gynecologic Oncology Group:
|
stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases 9-nitrocamptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013