RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of aminocamptothecin in treating patients with advanced cancer of the peritoneal cavity.

Condition	Treatment or Intervention	Phase
Gastrointestinal Cancer Pancreatic Cancer Liver Cancer Female Reproductive Cancer	Drug: aminocamptothecin colloidal dispersion	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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)

--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

--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

New York
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

Study chairs or principal investigators

Franco M. Muggia,  Study Chair,  Kaplan Cancer Center   

Study ID Numbers:  CDR0000066605; NYU-9753; NCI-T97-0123
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00003548
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08