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Docetaxel and Irinotecan in Treating Patients With Advanced Cancer of the Esophagus or Stomach
This study has been completed.
First Received: January 28, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004235
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and irinotecan in treating patients who have advanced cancer of the esophagus or stomach.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: docetaxel
Drug: irinotecan hydrochloride
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer
Drug Information available for: Irinotecan U 101440E Docetaxel Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Taxotere and Irinotecan (CPT-11) in Patients With Advanced Adenocarcinoma of the Lower Esophagus, Esophagogastric Junction, and Gastric Cardia

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

Study Start Date: January 2000
Detailed Description:

OBJECTIVES: I. Determine the objective tumor response rate in patients with advanced adenocarcinoma of the lower esophagus, esophagogastric junction, and gastric cardia treated with docetaxel and irinotecan. II. Determine time to progression and overall survival of patients treated treated with this regimen. III. Determine the toxic effects of this regimen in these patients. IV. Assess treatment response in these patients by determining the prevalence of dysphagia, anorexia, and swallowing ability at diagnosis and during treatment with this regimen.

OUTLINE: Patients receive irinotecan IV over 90 minutes followed by docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression. Patients achieving a complete response (CR) receive 2 additional courses after CR. Patients experiencing disease progression after a CR and 2 additional courses may be retreated with irinotecan and docetaxel. Dysphagia, anorexia, and swallowing ability are assessed before the first course of treatment and then at each tumor assessment. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 12-26 months.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the lower esophagus, esophagogastric junction, or gastric cardia that is considered unresectable and for which no curative therapy exists No other conventional forms of therapy available that would offer a reasonable chance of cure or significant palliation Gastric cardia is defined as no greater than 5 cm from the esophagogastric junction into the stomach Measurable disease At least 1 lesion that can be accurately measured in at least 1 dimension as at least 20 mm No nonmeasurable lesions only, including: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions No known untreated or treated symptomatic CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than ULN (less than 2.5 times ULN if alkaline phosphatase no greater than ULN) Alkaline phosphatase no greater than ULN (4 times ULN if AST no greater than ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Neurologic: No grade 2 or greater peripheral neuropathy of any etiology No uncontrolled seizure disorder Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Ability to complete questionnaires alone or with assistance No uncontrolled infection No chronic debilitating disease No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or other noninvasive carcinoma

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biologic therapy for recurrent or metastatic disease No concurrent biologic therapy No concurrent filgrastim (G-CSF) as primary prophylaxis Chemotherapy: Prior adjuvant chemotherapy after complete resection of original tumor allowed Prior neoadjuvant chemotherapy allowed No prior chemotherapy for recurrent or metastatic disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior adjuvant radiotherapy after complete resection of original tumor allowed Prior neoadjuvant radiotherapy allowed At least 4 weeks since prior radiotherapy No prior radiotherapy for recurrent or metastatic disease No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy except to CNS Surgery: See Disease Characteristics Prior surgical resection of primary tumor allowed At least 4 weeks since prior abdominal exploration with resection (3 weeks without resection)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004235

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CentraCare Clinic
Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Medcenter One Health System
Bismarck, North Dakota, United States, 58501
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57105-1080
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Jatoi A, Tirona MT, Cha SS, Alberts SR, Rowland KM, Morton RF, Nair S, Kardinal CG, Stella PJ, Mailliard JA, Sargen D, Goldberg RM. A phase II trial of docetaxel and CPT-11 in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and gastric cardia. Int J Gastrointest Cancer. 2002;32(2-3):115-23.
Tria Tirona M, Jatoi A, Cha SS, et al.: A phase II trial of CPT-11 and docetaxel in patients with metastatic esophageal cancer: preliminary toxicity data from the North Central Cancer Treatment Group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-605, 2002.

Study ID Numbers: CDR0000067479, NCCTG-N9941
Study First Received: January 28, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004235     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Irinotecan
Esophageal Cancer
Camptothecin
Recurrence
Carcinoma
Docetaxel
Digestive System Diseases
Stomach Diseases
Esophageal Disorder
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Stomach Cancer
Esophageal Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Esophageal Neoplasms
Irinotecan
Enzyme Inhibitors
Pharmacologic Actions
Camptothecin
Carcinoma
Docetaxel
Neoplasms
Stomach Diseases
Digestive System Diseases
Neoplasms by Site
Therapeutic Uses
Head and Neck Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009