Clinical trial NCT00003548: Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity
Official title: Phase I Study of Intraperitoneal Administration of 9-Amino-20(S)-Camptothecin to Patients With Cancer Predominantly Confined to the Peritoneal Cavity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: stage IV colon cancer
stage IV breast cancer
recurrent breast cancer
stage IV gastric cancer
recurrent gastric cancer
recurrent pancreatic cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
stage IV anal cancer
recurrent anal cancer
stage IV esophageal cancer
recurrent esophageal cancer
stage IV cervical cancer
recurrent cervical cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
stage IV vulvar cancer
recurrent vulvar cancer
stage IVA vaginal cancer
stage IVB vaginal cancer
recurrent vaginal cancer
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
advanced adult primary liver cancer
recurrent adult primary liver cancer
recurrent gestational trophoblastic tumor
stage IV endometrial carcinoma
recurrent endometrial carcinoma
unresectable gallbladder cancer
recurrent gallbladder cancer
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
recurrent small intestine cancer
carcinoma of the appendix
fallopian tube cancer
stage IV uterine sarcoma
recurrent uterine sarcoma
recurrent carcinoma of unknown primary
stage IV pancreatic cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Franco M. Muggia, MD
role: STUDY_CHAIR
References: