Docetaxel and Irinotecan in Treating Patients With Advanced Cancer of the Esophagus or Stomach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004235
Recruitment Status : Completed
First Posted : March 3, 2004
Last Update Posted : July 14, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

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 or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: docetaxel Drug: irinotecan hydrochloride Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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
Study Start Date : January 2000
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Arm Intervention/treatment
Experimental: irinotecan + docetaxel

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.

Drug: docetaxel Drug: irinotecan hydrochloride

Primary Outcome Measures :
  1. objective tumor response rate [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. time to progression [ Time Frame: Up to 5 years ]
  2. overall survival [ Time Frame: Up to 5 years ]
  3. treatment response [ Time Frame: Up to 5 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004235

United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
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
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic
Saint Cloud, Minnesota, United States, 56303
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, North Dakota
Medcenter One Health System
Bismarck, North Dakota, United States, 58501
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57105-1080
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Aminah Jatoi, MD Mayo Clinic

Publications of Results:
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.

Other Publications:
Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00004235     History of Changes
Other Study ID Numbers: NCCTG-N9941
CDR0000067479 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 3, 2004    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
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

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors