RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

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

Condition	Treatment or Intervention	Phase
stage IV gastric cancer recurrent gastric cancer stage IV esophageal cancer recurrent esophageal cancer adenocarcinoma of the stomach Adenocarcinoma of the Esophagus	Drug: irinotecan  Drug: paclitaxel  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the antitumor activity of irinotecan and paclitaxel in patients with metastatic or recurrent adenocarcinoma of the esophagus or stomach.
• Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia vs adenocarcinoma of the rest of the stomach).

Patients receive irinotecan IV over 90 minutes followed by paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 26-54 patients (13-27 per stratum) will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the esophagus (including the gastroesophageal junction) or stomach
• Inoperable metastatic or recurrent disease
• Incurable with chemotherapy, radiotherapy, surgery, or combination therapy
• Bidimensionally measurable disease
• At least 1 cm x 1 cm by CT scan or MRI
• Mediastinal or hilar lymph nodes at least 2 cm in longest dimension by CT scan or MRI
• No prior radiotherapy to only evaluable lesion
• No brain metastases
• No osseous metastasis as only site of disease

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 3 times upper limit of normal
• No known Gilbert's syndrome

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No unstable angina
• No myocardial infarction within the past 6 months
• No uncontrolled, clinically evident congestive heart failure

Other:

• No history of seizures
• No serious infection
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No other disease that would preclude study
• No psychiatric disorders that would preclude study
• No significant clinical neuropathy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered
• No more than 1 prior immunotherapy regimen for metastatic disease
• No concurrent immunotherapy

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy and recovered
• No prior paclitaxel or irinotecan
• No more than 1 prior chemotherapy regimen for metastatic disease except fluorouracil as an adjuvant or radiosensitizer
• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior limited radiotherapy and recovered
• No prior radiotherapy to major bone marrow-containing areas (pelvis or lumbar spine)
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• At least 1 week since prior minor surgery
• At least 3 weeks since prior major surgery
• Recovered from prior surgery

Other:

• At least 4 weeks since prior investigational therapy
• No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
• No other concurrent medication except analgesics, chronic treatments for concurrent medical conditions, or agents required for life-threatening medical problems
• No concurrent prochlorperazine on day of irinotecan administration

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States
Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States
Oregon
      OHSU Cancer Institute, Portland,  Oregon,  97201-3098,  United States

Study chairs or principal investigators

Joel Randolph Hecht, MD,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068711; UCLA-0001048; NCI-G01-1957
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00020761
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08