Status:
TERMINATED
Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor ce...
Detailed Description
OBJECTIVES: Primary \* Determine the pathologic complete response rate of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy in patients with locally advance...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction
- No T1-2, N0, M0 disease
- No palpable or biopsy-proven involvement of supraclavicular nodes or radiographically involved supraclavicular nodes (\> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic, or GE junction
- \+ Supraclavicular node involvement allowed provided there are upper thoracic esophagus primary lesions
- Patients with involvement of celiac nodes (stations 15-20) are eligible if the primary lesion is mid-thoracic, distal esophagus, or GE junction
- No evidence of distant metastases
- Tumor must be considered surgically resectable
- \- Patients with T4, N0 tumors that are potentially resectable are eligible
- No clinically relevant pleural or peritoneal effusion that is not amenable to drainage
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥ 12 weeks
- Absolute neutrophil count ≥1,500/mm\^3
- Platelet count ≥100,000/mm\^3
- Hemoglobin ≥10 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Creatinine clearance ≥ 45 mL/min
- No New York Heart Association class III or IV congestive heart failure
- Pregnant or nursing women are ineligible
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No other severe underlying disease that would preclude study entry
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
- No prior sensitivity or allergic reaction to pemetrexed disodium or carboplatin
- Able to swallow pills
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for esophageal cancer
- No prior radiotherapy field that overlapped the anticipated fields of study radiotherapy
- No prior radiotherapy to \> 30% of the marrow cavity
- Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) must be able to discontinue use 2 days prior, during, and 2 days after pemetrexed disodium administration (5 days prior for long-life NSAIDs)
- Patients must not have been receiving cyclooxygenase-2 inhibitors at study entry and while receiving protocol therapy
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00268437
Start Date
April 1 2006
End Date
March 1 2015
Last Update
July 6 2016
Active Locations (90)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
3
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
4
Graham Hospital
Canton, Illinois, United States, 61520