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Radiation Therapy, Pemetrexed...

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

Last Updated: 2016-07-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pemetrexed/Carboplatin

Pemetrexed+Carboplatin+Radiation

Group Type EXPERIMENTAL

carboplatin

Intervention Type DRUG

carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Pemetrexed

Intervention Type DRUG

Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

conventional surgery

Intervention Type PROCEDURE

neoadjuvant therapy

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).

Interventions

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carboplatin

carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Intervention Type DRUG

Pemetrexed

Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Intervention Type DRUG

conventional surgery

Intervention Type PROCEDURE

neoadjuvant therapy

Intervention Type PROCEDURE

radiation therapy

Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aminah Jatoi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

St. Anthony's Memorial Hospital

Effingham, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

InterCommunity Cancer Center of Western Illinois

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Valley Cancer Center

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status