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

Alliance for Clinical Trials in Oncology

Status and phase

Terminated

Phase 2

Conditions

Esophageal Cancer

Treatments

Procedure: neoadjuvant therapy

Drug: carboplatin

Radiation: radiation therapy

Procedure: conventional surgery

Drug: Pemetrexed

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00268437

NCCTG-N044E

CDR0000455635 (Registry Identifier)

NCI-2012-02678 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

* Determine the pathologic complete response rate of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy in patients with locally advanced esophageal cancer.

Secondary

Determine the activity, in terms of clinical response rate and adverse event profile of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy.
Determine the overall survival, time-to-progression, and time-to-treatment failure for patients receiving the above combined modality treatment.
Determine the surgical outcome for all patients who undergo esophagectomy.
Determine the time-to-disease recurrence and disease-free survival for patients who have a curative resection.
Determine quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily, 5 days a week, for 5 ½ weeks and concurrently receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who are eligible will undergo esophagectomy between 4-12 weeks after completion of radiotherapy.

Quality of life is assessed at baseline, immediately prior to day 22 of chemotherapy, and within 2 weeks prior to surgery.

After completion of study treatment, patients are followed periodically for approximately 4 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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