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Phase I Study to Evaluate the Combination Chemotherapy Regimen of Oxaliplatin Plus Irinotecan in Previously Treated Patients With Metastatic Gastrointestinal Cancer

Phase 1
18 Years
Not Enrolling
Anal Cancer, Colorectal Cancer, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Liver Cancer, Pancreatic Cancer, Small Intestine Cancer

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Trial Information

Phase I Study to Evaluate the Combination Chemotherapy Regimen of Oxaliplatin Plus Irinotecan in Previously Treated Patients With Metastatic Gastrointestinal Cancer

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) for the combination chemotherapy
regimen of oxaliplatin plus irinotecan when both drugs are given once a week for four weeks,
followed by a two week rest, in patients with metastatic gastrointestinal cancer. II.
Evaluate the toxicities of this combination chemotherapy when administered in this manner.
III. Determine the pharmacokinetics of platinum and irinotecan at the MTD for this
combination chemotherapy in this patient population.

OUTLINE: This is a dose escalation study. Patients receive oxaliplatin IV over 120 minutes,
immediately followed by irinotecan IV over 30 minutes, weekly for 4 weeks (days 1, 8, 15,
and 22). Courses are repeated every 42 days. Treatment continues in the absence of
unacceptable side effects or disease progression. Sequential dose escalation of oxaliplatin
is followed by sequential dose escalation of irinotecan. Dose escalation in cohorts of 3-6
patients each continues 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 toxic effects. Patients are followed approximately every 2-3 months.

PROJECTED ACCRUAL: A total of 2-36 patients will be accrued for this study within 18-36

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic gastrointestinal carcinoma
Measurable disease No CNS metastases No obstruction or partial obstruction of GI tract No
obstruction of genitourinary tract

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least
1,500/mm3 Platelet count at least 125,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL
Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled high blood
pressure, unstable angina, active congestive heart failure, myocardial infarction within
prior 6 months, or serious uncontrolled cardiac arrhythmia Neurological: No concurrent
symptomatic peripheral sensory neuropathy Other: No active or uncontrolled infection Not
pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
cisplatin, oxaliplatin, nitrosoureas, or mitomycin C 1 or 2 prior chemotherapy regimens
allowed (including irinotecan) Endocrine therapy: Not specified Radiotherapy: No prior
radiation therapy to whole pelvis, 30% or greater of bone marrow, and site of measurable
disease At least 4 weeks since prior radiation therapy and recovered Surgery: Not

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Nancy E. Kemeny, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 1998

Completion Date:

April 2002

Related Keywords:

  • Anal Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Gastric Cancer
  • Gastrointestinal Carcinoid Tumor
  • Liver Cancer
  • Pancreatic Cancer
  • Small Intestine Cancer
  • stage IV colon 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
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • recurrent small intestine cancer
  • stage IV pancreatic cancer
  • Anus Neoplasms
  • Carcinoid Tumor
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Liver Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Intestinal Neoplasms



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