Clinical trial · Interventional

Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer

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

NCT00003427CI-TRIAL-00011080completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment.

Conditions

Conditions (10)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Anal Cancer	Malignant Anal Neoplasm	CURATED_EXACT	0.92
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92
Extrahepatic Bile Duct Cancer	Malignant Extrahepatic Bile Duct Neoplasm	ALIAS	0.90
Gallbladder Cancer	Malignant Gallbladder Neoplasm	CURATED_EXACT	0.92
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80
Gastrointestinal Carcinoid Tumor	Digestive System Neuroendocrine Tumor G1	ALIAS	0.90
Liver Cancer	Malignant Liver Neoplasm	CURATED_EXACT	0.92
Pancreatic Cancer	Malignant Pancreatic Neoplasm

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
irinotecan hydrochloride	Drug	Irinotecan	ALIAS
oxaliplatin	Drug	Oxaliplatin	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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 specified

References

Publications (1)

RESULTKemeny N, Tong W, Gonen M, Stockman J, Di Lauro C, Teitcher J, White P, Price C, Saltz L, Sharma S, Graham MA. Phase I study of weekly oxaliplatin plus irinotecan in previously treated patients with metastatic colorectal cancer. Ann Oncol. 2002 Sep;13(9):1490-6. doi: 10.1093/annonc/mdf247. PMID 12196376

Registry

Dates and enrollment

Start: Apr 1, 1998
Primary completion: Apr 1, 2002
Completion: Apr 1, 2002
First posted: Apr 27, 2004
Last update posted: Jun 26, 2013
Enrollment: 36 (estimated)
Lead sponsor: Memorial Sloan Kettering Cancer Center OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: 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

Data updated 22 days agoSource updated Jun 26, 2013source: clinicaltrials

Locations

Locations by country (1)

Country