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

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00268437

Purpose

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	Intervention	Phase
Esophageal Cancer	Drug: carboplatin Drug: pemetrexed disodium Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial of Preoperative Radiation and Chemotherapy (Pemetrexed and Carboplatin) for Locally Advanced Esophageal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Radiation Therapy Surgery

Drug Information available for: Carboplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Pathologic complete response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical tumor response [ Designated as safety issue: No ]
Pathologic tumor response [ Designated as safety issue: No ]
Time to disease progression [ Designated as safety issue: No ]
Surgical outcome [ Designated as safety issue: No ]
Time to death [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Time to treatment failure [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	April 2006
Estimated Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268437

Show 90 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Investigator:	Francis C. Nichols, MD	Mayo Clinic
Investigator:	Robert F. Marschke, MD	Mayo Clinic Scottsdale
Investigator:	Leonard L. Gunderson, MD	Mayo Clinic Scottsdale
Investigator:	Matthew Callister, MD	Mayo Clinic
Study Chair:	Aminah Jatoi, MD	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000455635, NCCTG-N044E
Study First Received:	December 20, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00268437 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage III esophageal cancer
stage II esophageal cancer

Study placed in the following topic categories:

Antimetabolites
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Folate
Esophageal Cancer
Carboplatin
Folinic Acid
Folic Acid Antagonists
Squamous Cell Carcinoma
Vitamin B9

Carcinoma
Folic Acid
Pemetrexed
Digestive System Diseases
Esophageal Disorder
Head and Neck Neoplasms
Epidermoid Carcinoma
Gastrointestinal Neoplasms
Esophageal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
Enzyme Inhibitors
Carboplatin
Folic Acid Antagonists

Pharmacologic Actions
Pemetrexed
Neoplasms
Digestive System Diseases
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on September 10, 2009