Status:
COMPLETED
Pemetrexed, Cisplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growt...
Detailed Description
OBJECTIVES: Primary * To establish the maximum tolerated dose of pemetrexed disodium in combination with cisplatin and standard-dose radiotherapy in patients with stage III or IV esophageal or gastr...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of esophageal or gastroesophageal junction carcinoma
- Stage III or IV disease
- Treatment with chemoradiotherapy is considered appropriate
- Measurable or evaluable disease
- Clinically significant pleural or pericardial effusions or ascites allowed provided they were drained prior to study entry
- No pleurodesis within the past 2 weeks
- Controlled brain metastasis allowed provided patient is clinically stable with no signs of progression by MRI or CT scan of the brain ≥ 60 days after completion of treatment AND is asymptomatic and does not require steroids
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- WBC ≥ 2,500/mm\^3
- ANC ≥ 1,500/mm\^3
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/mm\^3
- Total bilirubin normal
- Alkaline phosphatase AND AST and ALT meeting the following criteria:
- Alkaline phosphatase normal AND AST or ALT ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN for patients with liver metastases)
- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal
- Creatinine clearance ≥ 45 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- Able to take folic acid, vitamin B\_12, or corticosteroids
- No known severe hypersensitivity reaction to study drugs
- No uncontrolled serious active infection
- No pre-existing peripheral neuropathy \> grade 1
- No significant cardiac disease, including any of the following:
- Uncontrolled high blood pressure
- Unstable angina
- Congestive heart failure within the past 6 months
- Left ventricular ejection fraction below the lower limit of normal
- Myocardial infarction within the past year
- Serious cardiac arrhythmias requiring medication
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic therapy regimens
- No prior radiotherapy to gastric/esophageal fields
- No aspirin or other NSAID before and after pemetrexed disodium administration
- No concurrent colony-stimulating factors (CSF) to maintain WBC and ANC eligibility values
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00701857
Start Date
February 1 2008
End Date
September 1 2015
Last Update
April 20 2016
Active Locations (1)
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1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724