We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00268437
Recruitment Status : Terminated (Trial closed early because, during an interim analysis, the primary endpoint fell short.)
First Posted : December 22, 2005
Results First Posted : March 27, 2015
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: carboplatin Drug: Pemetrexed Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Preoperative Radiation and Chemotherapy (Pemetrexed and Carboplatin) for Locally Advanced Esophageal Cancer
Study Start Date : April 2006
Primary Completion Date : January 2008
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pemetrexed/Carboplatin
Pemetrexed+Carboplatin+Radiation
Drug: carboplatin
carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Drug: Pemetrexed
Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.
Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: 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).


Outcome Measures

Primary Outcome Measures :
  1. Pathologic Complete Response Rate [ Time Frame: 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 :
  1. Overall Survival [ Time Frame: From baseline to 4 years ]
    Time from registration to death due to any cause.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268437


  Show 90 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
More Information

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00268437     History of Changes
Other Study ID Numbers: NCCTG-N044E
NCI-2012-02678 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000455635 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: December 22, 2005    Key Record Dates
Results First Posted: March 27, 2015
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage III esophageal cancer
stage II esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors