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

A Phase II Study of Taxotere and Irinotecan (CPT-11) in Patients With Advanced Adenocarcinoma of the Lower Esophagus, Esophagogastric Junction, and Gastric Cardia

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Esophageal Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: irinotecan hydrochloride

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
• Enrollment (Actual): 47
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
objective tumor response rate	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	Up to 5 years
time to progression	Up to 5 years
treatment response	Up to 5 years

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Jatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535.
• 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. doi: 10.1385/ijgc:32:2-3:115.
• 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 record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): August 1, 2004
• Study Completion (Actual): August 1, 2004

Study Registration Dates

• First Submitted: January 28, 2000
• First Submitted That Met QC Criteria: March 2, 2004
• First Posted (Estimate): March 3, 2004

Study Record Updates

• Last Update Posted (Estimate): July 14, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: stage IV gastric cancer; recurrent gastric cancer; stage II esophageal cancer; stage III esophageal cancer; adenocarcinoma of the stomach; adenocarcinoma of the esophagus; recurrent esophageal cancer; stage IV esophageal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Neoplasms; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Docetaxel; Irinotecan
• Other Study ID Numbers: NCCTG-N9941; CDR0000067479 (Registry Identifier: PDQ (Physician Data Query))