Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2002-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors

NCT00004242

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

NCT00003742

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Cisplatin and Irinotecan in Treating Patients With Locally Advanced or Metastatic Esophageal or Gastric Cancer

NCT00003055

Esophageal Cancer Gastric Cancer

COMPLETED PHASE2

Capecitabine and Oxaliplatin in Treating Patients With Advanced or Metastatic Colorectal Cancer

NCT00004187

Colorectal Cancer

COMPLETED PHASE1/PHASE2

Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors

NCT00074321

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anal Cancer Colorectal Cancer Esophageal Cancer Extrahepatic Bile Duct Cancer Gallbladder Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Liver Cancer Pancreatic Cancer Small Intestine Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

irinotecan hydrochloride

Intervention Type DRUG

oxaliplatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 specified

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No