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



Status:Completed
Conditions:Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2000
End Date:August 2004

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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

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.

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.

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)
We found this trial at
19
sites
Wichita, Kansas 67214
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Ann Arbor, Michigan 48106
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Bismarck, North Dakota 58501
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Cedar Rapids, Iowa 52403
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Danville, Pennsylvania 17822
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Danville, PA
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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Des Moines, IA
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Duluth, MN
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Fargo, North Dakota 58122
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Fargo, ND
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New Orleans, Louisiana 70121
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New Orleans, LA
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Omaha, NE
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Peoria, IL
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Rapid City, SD
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Regina, Saskatchewan
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Regina,
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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Saint Cloud, Minnesota 56303
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Saint Cloud, MN
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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Sioux City, Iowa 51101
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Sioux City, IA
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Sioux Falls, South Dakota 57104
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Sioux Falls, SD
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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Urbana, IL
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