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A Phase II Trial of Preoperative Radiation and Chemotherapy (Pemetrexed and Carboplatin) for Locally Advanced Esophageal Cancer

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

A Phase II Trial of Preoperative Radiation and Chemotherapy (Pemetrexed and Carboplatin) for Locally Advanced Esophageal Cancer



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


- Determine the activity, in terms of clinical response rate and adverse event profile of
radiotherapy, pemetrexed disodium, and carboplatin when administered prior to

- 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 to surgery 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

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

Inclusion Criteria


- 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


- 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


- No prior chemotherapy for esophageal cancer

- No prior radiotherapy field that overlapped the anticipated fields of study

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response rate

Safety Issue:


Principal Investigator

Francis C. Nichols, MD

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • stage III esophageal cancer
  • stage II esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Hurley Medical Center Flint, Michigan  48503
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Foote Hospital Jackson, Michigan  49201
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
Seton Cancer Institute - Saginaw Saginaw, Michigan  48601
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's Hospital St Paul, Minnesota  55102
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health Campus Woodbury, Minnesota  55125
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Rapid City Regional Hospital Rapid City, South Dakota  57709
Methodist Medical Center of Illinois Peoria, Illinois  61636
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
InterCommunity Cancer Center of Western Illinois Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
Valley Cancer Center Spring Valley, Illinois  61362
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Bismarck Cancer Center Bismarck, North Dakota  58501
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
St. Anthony's Memorial Hospital Effingham, Illinois  62401
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Galesburg Clinic, PC Galesburg, Illinois  61401
AnMed Cancer Center Anderson, South Carolina  29621
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Albert Lea Cancer Center at Albert Lea Medical Center Albert Lea, Minnesota  56007