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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005607
First received: May 2, 2000
Last updated: December 18, 2013
Last verified: July 2000
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: FOLFIRI regimen
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of CPT-11 and 5-FU/LCV in Patients With Previously Untreated Gastric Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
Detailed Description:

OBJECTIVES: I. Determine the response rate of patients with metastatic or recurrent adenocarcinoma of the stomach or gastroesophageal junction when treated with irinotecan, fluorouracil, and leucovorin calcium. II. Determine the qualitative and quantitative toxicity, and reversibility of toxicity, of this regimen in this patient population.

OUTLINE: Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV over 15 minutes, and fluorouracil IV once weekly for 4 weeks followed by 2 weeks of rest. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed at 30 days, and then until death.

PROJECTED ACCRUAL: A total of 18-37 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005607

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Al B. Benson, MD, FACP Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005607     History of Changes
Other Study ID Numbers: CDR0000067731, NU-VCCGI9801, P-UPJOHN-976475148, NCI-G00-1740
Study First Received: May 2, 2000
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV gastric cancer
recurrent gastric cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Irinotecan
Camptothecin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex

ClinicalTrials.gov processed this record on July 31, 2014