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Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00002671
First received: November 1, 1999
Last updated: November 8, 2012
Last verified: May 2006

November 1, 1999
November 8, 2012
December 1995
February 2001   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00002671 on ClinicalTrials.gov Archive Site
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Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
PHASE II STUDY OF 9-20-S-AMINO-CAMPTOTHECIN (9-AC) AS SECOND LINE THERAPY IN ADVANCED OVARIAN CARCINOMA

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 unresectable epithelial ovarian cancer that has been previously treated with platinum-based chemotherapy.

OBJECTIVES: I. Determine the objective response rate in patients with advanced, recurrent, or inoperable ovarian epithelial cancer treated with aminocamptothecin as second-line therapy. II. Determine the toxic effects of this regimen in these patients. III. Correlate the topoisomerase-I levels with response in patients with accessible tumors treated with this regimen.

OUTLINE: Patients are stratified according to disease (measurable vs nonmeasurable). (The measurable disease stratum closed to accrual effective 08/1998.) Patients receive aminocamptothecin IV continuously on days 1-3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 4 additional courses past CR. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within approximately 15 months. (The measurable disease stratum closed to accrual effective 08/1998.)

Interventional
Phase 2
Primary Purpose: Treatment
Ovarian Cancer
Drug: aminocamptothecin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2001   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically proven advanced, recurrent, or inoperable ovarian epithelial cancer Previously treated with 1 platinum-containing chemotherapy regimen Bidimensionally measurable or reproducibly measurable disease in 2 dimensions on CT scan (The measurable disease stratum closed to accrual effective 08/1998) OR Evaluable but radiographically nonmeasurable disease with CA-125 more than 50 units/mL on 2 measurements at least 1 week apart

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction, congestive heart failure, or other significant cardiac disease within the past 6 months No uncontrolled hypertension Other: No significant active infection (e.g., pneumonia, peritonitis, or wound abscess) No uncontrolled metabolic disease (e.g., diabetes mellitus or hypothyroidism) No asthma (even if controlled with medication) No other serious concurrent illness No dementia or altered mental status that would preclude informed consent No other malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since prior investigational agents

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002671
CDR0000064290, NYU-9501, E-9501, NCI-T95-0001D
Not Provided
New York University School of Medicine
New York University School of Medicine
  • National Cancer Institute (NCI)
  • Eastern Cooperative Oncology Group
Study Chair: Howard S. Hochster, MD New York University School of Medicine
New York University School of Medicine
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP