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Phase I Study of Intraperitoneal Administration of 9-Amino-20(S)-Camptothecin to Patients With Cancer Predominantly Confined to the Peritoneal Cavity

Phase 1
18 Years
Not Enrolling

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Trial Information

Phase I Study of Intraperitoneal Administration of 9-Amino-20(S)-Camptothecin to Patients With Cancer Predominantly Confined to the Peritoneal Cavity

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

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Franco M. Muggia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

Related Keywords:

  • Cancer
  • 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



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