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

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

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

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

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • 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
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



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