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Home > "I" Clinical Trials Conditions > Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach  Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
For Condition: recurrent gastric cancer,adenocarcinoma of the stomach,stage 4 gastric cancer,stage 4 esophageal cancer,Adenocarcinoma of the Esophagus,recurrent esophageal cancer
Status: No longer recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoelHecht, Study Chair, Jonsson Comprehensive Cancer Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
OHSU Cancer Institute
Portland, Oregon, 97201-3098
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Additional Information:
Study ID Numbers: CDR0000068711; UCLA-0001048,NCI-G01-1957
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020761
Other Recurrent Esophageal Cancer Studies:
1. Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
2. Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
3. Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
4. Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
5. Positron Emission Tomography in Determining Stage of Esophageal Cancer
Related Studies:
Other recurrent esophageal cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
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