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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
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

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


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 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
years.

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

Inclusion 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:

- 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response rate

Safety Issue:

No

Principal Investigator

Francis C. Nichols, MD

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000455635

NCT ID:

NCT00268437

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

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Hurley Medical CenterFlint, Michigan  48503
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rapid City Regional HospitalRapid City, South Dakota  57709
Methodist Medical Center of IllinoisPeoria, Illinois  61636
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Bismarck Cancer CenterBismarck, North Dakota  58501
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
St. Anthony's Memorial HospitalEffingham, Illinois  62401
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Galesburg Clinic, PCGalesburg, Illinois  61401
AnMed Cancer CenterAnderson, South Carolina  29621
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Albert Lea Cancer Center at Albert Lea Medical CenterAlbert Lea, Minnesota  56007