Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Cancer of the Stomach or Esophagus

NCT00005607 | Unknown Phase 2

• 4 other identifiers: CDR0000067731NU-VCCGI9801P-UPJOHN-976475148NCI-G00-1740
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

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 II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent cancer of the stomach or esophagus.

Conditions

Esophageal Cancer; Gastric Cancer

Keywords

stage IV gastric cancer; recurrent gastric cancer; stage IV esophageal cancer; recurrent esophageal cancer; adenocarcinoma of the stomach; adenocarcinoma of the esophagus

Interventions

FOLFIRI regimen DRUG

fluorouracil DRUG

irinotecan hydrochloride DRUG

leucovorin calcium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or recurrent adenocarcinoma of the stomach or gastroesophageal junction Bidimensionally measurable or evaluable disease Mediastinal or hilar lymph nodes assessed by CT or MRI scan must be at least 2 cm in diameter to be considered measurable Must not be curable with a combination of chemotherapy and radiotherapy No brain metastases No osseous metastasis as only site of disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal No known Gilbert's syndrome Renal: Creatinine no greater than 1.5 mg/dL Calcium no greater than 12 mg/dL No symptomatic hypercalcemia under treatment Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of seizures No serious concurrent infections or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by study complications No psychiatric disorders that would preclude study compliance No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No uncontrolled diabetes mellitus (i.e., random blood sugar less than 250 mg) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for metastatic disease No concurrent immunotherapy Chemotherapy: See Disease Characteristics No prior chemotherapy for metastatic disease No prior radiosensitizing chemotherapy in metastatic setting At least 6 months since prior adjuvant therapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to major bone marrow containing areas (e.g., pelvis, lumbar spine) No prior radiotherapy to only evaluable lesion No concurrent radiotherapy Surgery: At least 1 week since minor surgery and 3 weeks since major surgery and recovered Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis No concurrent prochlorperazine on day of irinotecan administration No other concurrent medications except for analgesics, chronic treatments for concurrent medical conditions, or agents required for life threatening medical problems

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Robert H. Lurie Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5265, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Fluorouracil; Irinotecan; Leucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Al B. Benson, MD, FACP

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: August 10, 2004
• Study Start: February 1, 2000
• Last Updated: December 19, 2013

Record last verified: 2000-07

Locations

US (4)