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A Phase I Study of Intraperitoneal Oxaliplatin Alone and in Combination With Intraperitoneal Floxuridine and Leucovorin in Patients With Advanced Metastatic Cancer Confined to the Peritoneal Cavity

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase I Study of Intraperitoneal Oxaliplatin Alone and in Combination With Intraperitoneal Floxuridine and Leucovorin in Patients With Advanced Metastatic Cancer Confined to the Peritoneal Cavity


- Determine the maximum tolerated dose of intraperitoneal oxaliplatin with or without
intraperitoneal floxuridine and leucovorin calcium in patients with metastatic cancer
confined to the peritoneal cavity.

- Determine dose limiting and nondose limiting toxicities and pharmacokinetics of these
treatment regimens in this patient population.

OUTLINE: This is a dose escalation study of oxaliplatin.

Patients receive intraperitoneal (IP) oxaliplatin over 1 hour on day 1 every 2 weeks for 2

Beginning at course 3, patients receive oxaliplatin with floxuridine and leucovorin calcium
IP on day 1 and floxuridine and leucovorin calcium IP alone on days 2 and 3. Treatment
repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients with complete surgical resection of disease receive a total of 6 courses of
combination chemotherapy.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin 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.

PROJECTED ACCRUAL: A total of 3-40 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed metastatic or unresectable cancer largely
confined to the peritoneal cavity

- Fully resected and/or electrocauterized metastatic disease involving the
peritoneum (stage IV, no residual disease) allowed

- No known brain metastases



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin normal

- SGOT/SGPT no greater than 2.5 times upper limit of normal


- Creatinine normal OR

- Creatinine clearance at least 60 mL/min


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- No history of allergy to platinum compounds or antiemetics that would preclude study

- No other uncontrolled illness (e.g., active infection)

- No evidence of neuropathy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or
nitrosoureas) and recovered

Endocrine therapy:

- Not specified


- At least 4 weeks since prior radiotherapy and recovered


- See Disease Characteristics


- No other concurrent investigational agents

- No concurrent antiretroviral therapy (HAART)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2000

Completion Date:

Related Keywords:

  • Cancer
  • stage IV colon cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • recurrent pancreatic cancer
  • recurrent colon cancer
  • regional neuroblastoma
  • stage 4S neuroblastoma
  • recurrent neuroblastoma
  • regional gastrointestinal carcinoid tumor
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • gastrinoma
  • small intestine adenocarcinoma
  • small intestine lymphoma
  • small intestine leiomyosarcoma
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • recurrent small intestine cancer
  • insulinoma
  • recurrent islet cell carcinoma
  • WDHA syndrome
  • somatostatinoma
  • pancreatic polypeptide tumor
  • glucagonoma
  • regional pheochromocytoma
  • metastatic pheochromocytoma
  • recurrent pheochromocytoma
  • extragonadal germ cell tumor
  • liver metastases
  • malignant ascites
  • newly diagnosed carcinoma of unknown primary
  • carcinoma of the appendix
  • pseudomyxoma peritonei
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • recurrent carcinoma of unknown primary
  • gastrointestinal stromal tumor
  • stage IV pancreatic cancer
  • Neoplasm Metastasis



Memorial Sloan-Kettering Cancer Center New York, New York  10021