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

Phase 2

Terminated

• Conditions: Esophageal Cancer
• Interventions: Drug: carboplatin; Drug: Pemetrexed; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy

• Registration Number: NCT00268437
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2005-12-20
• Study First Submitted QC: 2005-12-20
• Study First Posted: 2005-12-22
• Study Start: 2006-04
• Primary Completion: 2008-01
• Study Completion: 2015-03
• Results First Submitted: 2015-03-09
• Results First Submitted QC: 2015-03-16
• Results First Posted: 2015-03-27
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pemetrexed/Carboplatin	radiation therapy	Pemetrexed+Carboplatin+Radiation
Pemetrexed/Carboplatin	carboplatin	Pemetrexed+Carboplatin+Radiation
Pemetrexed/Carboplatin	Pemetrexed	Pemetrexed+Carboplatin+Radiation
Pemetrexed/Carboplatin	conventional surgery	Pemetrexed+Carboplatin+Radiation
Pemetrexed/Carboplatin	neoadjuvant therapy	Pemetrexed+Carboplatin+Radiation

Primary Outcome Measures

Name	Time	Method
Pathologic Complete Response Rate	Baseline to time of surgery (around 10 - 18 weeks post-baseline)	The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From baseline to 4 years	Time from registration to death due to any cause.

Trial Locations

Locations (90)

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Rush-Copley Cancer Care Center; 🇺🇸 Aurora, Illinois, United States

Graham Hospital; 🇺🇸 Canton, Illinois, United States

Memorial Hospital; 🇺🇸 Carthage, Illinois, United States

St. Anthony's Memorial Hospital; 🇺🇸 Effingham, Illinois, United States

Eureka Community Hospital; 🇺🇸 Eureka, Illinois, United States

Galesburg Clinic, PC; 🇺🇸 Galesburg, Illinois, United States

Galesburg Cottage Hospital; 🇺🇸 Galesburg, Illinois, United States

InterCommunity Cancer Center of Western Illinois; 🇺🇸 Galesburg, Illinois, United States

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