Phase I Study of Intraperitoneal Administration of 9-Amino-20(S)-Camptothecin to Patients With Cancer Predominantly Confined to the Peritoneal Cavity
aminocamptothecin colloidal dispersion
Urogenital Diseases+74
+ Genital Diseases
+ Adenocarcinoma
Treatment Study
Summary
Study start date: August 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the qualitative and quantitative toxicities of intraperitoneal aminocamptothecin colloidal dispersion administered every 28 days in 6 applications over a 12 day period in patients with advanced cancer confined to the peritoneal cavity. II. Determine the maximum tolerated dose of aminocamptothecin colloidal dispersion on this novel schedule in this patient population. III. Obtain pharmacological and biochemical data as potential predictors of responses and/or drug toxicities in these patients. IV. Document the presence and degree of antitumor activity of this regimen in this patient population. OUTLINE: This is a dose escalation study. Patients receive intraperitoneal aminocamptothecin colloidal dispersion (9-AC) over 30-60 minutes in 6 applications over a 12 day period (days 1, 3, 5, 8, 10, and 12). Courses are repeated every 28 days. Treatment continues for 4-6 courses in the absence of unacceptable toxic effects or disease progression. The dose of 9-AC is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed until death. PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued for this study within 18 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced malignancy involving the peritoneal cavity, excluding leukemia and lymphoma Patients with ovarian cancer must have received prior standard therapy Predominantly small tumor metastases less than 1.0 cm in diameter including: Ovarian cancer with epithelial histology Other gynecological tumors Breast cancer Gastric cancer Colorectal cancer Appendiceal cancer Pancreatic cancer Unknown primary cancer Other malignancies with predominantly intraperitoneal manifestation No extensive intraperitoneal adhesions that cannot be easily lysed laparoscopically or by laparotomy No symptomatic disease outside the peritoneal cavity Asymptomatic disease outside the peritoneum considered (e.g., bone lesions) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and/or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, United StatesOpen NYU School of Medicine's Kaplan Comprehensive Cancer Center in Google Maps