A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer

NCT ID: NCT00383266

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-06-30

Brief Summary

This is a study of an investigational agent, pemetrexed, in combination with a standard chemotherapy drug, carboplatin, for treatment of patients with metastatic esophageal cancer.

Conditions

Esophageal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pemetrexed + Carboplatin

• Pemetrexed 500 mg/m^2 IV over 10 minutes
• Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
• Each cycle will last 21 days.

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Interventions

Pemetrexed

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must have a histologically or cytologically proven metastatic or recurrent esophageal cancer. Both adenocarcinoma and squamous carcinoma are eligible for the study. Patients with small cell carcinoma or sarcoma of the esophagus are not eligible for the study.
• Patients may have had no prior chemotherapy treatment for metastatic esophageal cancer. Patients may have had chemotherapy with 5-FU combined with definitive radiotherapy for curative intent in the adjuvant, neoadjuvant, or definite setting for locally advanced esophageal cancer, if no less than one year prior to trial enrollment. Patients may not have received pemetrexed in the past.
• Patients who have had radiotherapy for esophageal cancer must have completed radiotherapy at least four weeks prior to entry in the study.
• Patients need to have measurable disease.
• Lesions that are not considered measurable include the following:

• Bone lesions
• Brain metastases or leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• Tumor lesions situated in a previously irradiated area
• ECOG) performance status of 0-2.
• Life expectancy of >=12 weeks.
• Patients must have adequate bone marrow function defined as: white blood cells (WBC) >= 3000/mm^3, absolute neutrophil count (ANC) >= 1,500/mm^3, hemoglobin >= 9.0 g/dL, and platelet count >= 100,000/mm^3.
• Patients must have adequate liver function defined as: Bilirubin <= 1.5 x institutional normal and ALT/AST < 3 x institutional normal.
• Patients must have adequate renal function defined as: serum creatinine <= 3.0 mg/dL and creatinine clearance >= 45 mL/min.
• Radiation therapy for brain metastases should be completed at least four weeks prior to enrollment to this protocol.
• Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or uncontrolled symptomatic cardiac arrhythmia.
• Patients must be able to be compliant with premedications of dexamethasone, folic acid, and vitamin B12.
• For all sexually active women of child-bearing age, the use of adequate contraception (hormonal or barrier method of birth control) will be required prior to study entry and for the duration of study participation.
• Age >= 18 years.

• Written consent.
• Ibuprofen (400 mg qid) can be administered with Alimta in patients with normal renal function (creatinine clearance > 80 mL/min

Exclusion Criteria

• Patients with third-space fluid (pleural effusions, ascites, etc.) uncontrolled by drainage.
• Pregnant or nursing females
• Patients who have had pre-existing neuropathy greater than or equal to grade 2.
• Patients with known active CNS metastases.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Q. Baggstrom, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

06-0541 / 201103198

Identifier Type: -

Identifier Source: org_study_id