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| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2000 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | January 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003523 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aminocamptothecin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Cancer of the Peritoneum | ||||
| Official Title ICMJE | Evaluation of Aminocamptothecin (9-AC, NSC #603071) in Recurrent, Platinum Resistant and Refractory Ovarian Cancer and Primary Peritoneal Carcinoma | ||||
| Brief Summary | 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 aminocamptothecin in treating patients with recurrent or refractory ovarian epithelial cancer or primary cancer of the peritoneum. |
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| Detailed Description | OBJECTIVES: I. Estimate the antitumor activity of aminocamptothecin colloidal dispersion in patients with platinum-resistant recurrent or refractory ovarian cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of aminocamptothecin colloidal dispersion in this patient population. OUTLINE: Patients receive aminocamptothecin colloidal dispersion IV over 120 hours weekly for two of every three weeks. Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 23-56 patients will be accrued for this study within 5-12 months. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: aminocamptothecin colloidal dispersion | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Miller DS, Blessing JA, Waggoner S, Schilder J, Sorosky J, Bloss J, Schilder R. Phase II evaluation of 9-aminocamptothecin (9-AC, NSC #603071) in platinum-resistant ovarian and primary peritoneal carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2005 Jan;96(1):67-71. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent ovarian epithelial cancer or primary peritoneal carcinoma Progressive disease on platinum-based treatment alone or in combination Two prior treatment regimens allowed only if other regimen was paclitaxel OR recurrence within 6 months of chemotherapy Measurable disease Not eligible for a higher priority GOG protocol PATIENT CHARACTERISTICS: Age: 13 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection Not pregnant Fertile patients must use effective contraception At least 5 years since prior malignancy; no prior chemotherapy or radiotherapy for that malignancy No concurrent malignancy other than non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No prior treatment with aminocamptothecin Endocrine therapy: At least 4 weeks since prior endocrine therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to site(s) of measurable disease used on this trial No prior radiotherapy to more than 25% of marrow-bearing areas Surgery: At least 4 weeks since prior surgery |
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| Gender | Female | ||||
| Ages | 13 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003523 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000066567, GOG-126I | ||||
| Study Sponsor ICMJE | Gynecologic Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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