Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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 cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed disodium and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Pemetrexed

Criteria

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