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

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Sponsored by
Robert H. Lurie Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Indiana University Cancer Center
  • University of Pennsylvania Cancer Center
  • Vanderbilt Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
December 18, 2013
Sponsor
Robert H. Lurie Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005607
Brief Title
Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Cancer of the Stomach or Esophagus
Official Title
A Phase II Study of CPT-11 and 5-FU/LCV in Patients With Previously Untreated Gastric Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2000
Overall Recruitment Status
Unknown status
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Robert H. Lurie Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Al B. Benson, MD, FACP
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5265
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

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

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