Esophageal Cancer Clinical Trial

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

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.

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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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

27

Study ID:

NCT00268437

Recruitment Status:

Terminated

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 67 Locations for this study

See Locations Near You

Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Graham Hospital
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
St. Anthony's Memorial Hospital
Effingham Illinois, 62401, United States
Eureka Community Hospital
Eureka Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex
Hopedale Illinois, 61747, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Kewanee Hospital
Kewanee Illinois, 61443, United States
McDonough District Hospital
Macomb Illinois, 61455, United States
BroMenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center
Normal Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
Illinois Valley Community Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley Illinois, 61362, United States
Valley Cancer Center
Spring Valley Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa, 52403, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Hospital
Jackson Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48912, United States
Seton Cancer Institute - Saginaw
Saginaw Michigan, 48601, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
Albert Lea Cancer Center at Albert Lea Medical Center
Albert Lea Minnesota, 56007, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Duluth Clinic Cancer Center - Duluth
Duluth Minnesota, 55805, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth Minnesota, 55805, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Meeker County Memorial Hospital
Lichfield Minnesota, 55355, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee Minnesota, 55379, United States
HealthEast Cancer Care at St. Joseph's Hospital
St Paul Minnesota, 55102, United States
Park Nicollet Cancer Center
St. Louis Park Minnesota, 55416, United States
Regions Hospital Cancer Care Center
St. Paul Minnesota, 55101, United States
United Hospital
St. Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury Minnesota, 55125, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Bismarck Cancer Center
Bismarck North Dakota, 58501, United States
Medcenter One Hospital Cancer Care Center
Bismarck North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck North Dakota, 58502, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, United States
AnMed Cancer Center
Anderson South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

27

Study ID:

NCT00268437

Recruitment Status:

Terminated

Sponsor:


Alliance for Clinical Trials in Oncology

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