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Home > "A" Clinical Trials Conditions > Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer  Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
For Condition: recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group,Kaplan Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Assess the objective response rate to prolonged intravenous aminocamptothecin as second-line therapy in women with recurrent or inoperable epithelial ovarian cancer previously treated with chemotherapy. II. Describe the toxicities associated with this regimen. III. Correlate topoisomerase-I levels with response in patients with accessible tumors. PROTOCOL OUTLINE: Single-Agent Chemotherapy. Aminocamptothecin, 9-AC, NSC-603071. PROJECTED ACCRUAL: 30 patients/stratum will be entered over approximately 15 months. If there is no response in the first 14 patients, the study will close.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically diagnosed epithelial ovarian cancer previously treated with 1 prior platinum-containing chemotherapy regimen - Measurable or evaluable lesions (i.e., evaluable but radiographically nonmeasurable with CA-125 greater than 50 units/mL on 2 measurements at least 1 week apart) (Measurable stratum closed) --Prior/Concurrent Therapy-- - No more than 1 prior chemotherapy regimen (see Disease Characteristics); At least 4 weeks since any investigational agents; No concurrent chemotherapy, radiotherapy, or immunotherapy --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0 or 1 - Life expectancy: At least 3 months - Hematopoietic: Absolute neutrophil count at least 1500/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: None of the following within 6 months: Myocardial infarction; Congestive heart failure; Other significant cardiac disease; No uncontrolled hypertension - Other: No significant active infection (e.g., pneumonia, peritonitis, wound abscess); No uncontrolled metabolic disease (e.g., diabetes mellitus, hypothyroidism); No asthma (even if controlled with medication); No other serious intercurrent illness; No neurologic or psychiatric condition that would preclude informed consent; No second malignancy except: Curatively treated nonmelanomatous skin cancer; Curatively treated in situ cervical carcinoma; Negative serum pregnancy test required of fertile women within 1 week of entry; Effective contraception required of fertile women - Blood/body fluid analyses within 2 weeks prior to registration; Imaging/exams for tumor measurement within 2 weeks prior to registration; Other screening exams within 6 weeks prior to registration
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardHochster, Study Chair, Kaplan Cancer Center
Overlook Hospital
Summit, New Jersey, 07902-0220
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Riverview Medical Center
Red Bank, New Jersey, 07701
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Additional Information:
Study ID Numbers: CDR0000064290; NYU-9501,NCI-T95-0001D
Study Start Date: November 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002671
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Refractory or Recurrent Ovarian Cancer
2. Carboplatin With or Without Liposomal Doxorubicin in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
3. Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
4. Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer
5. Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
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