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

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00383266
• Other study ID #: 06-0541 / 201103198
• Status: Terminated
• Phase: Phase 2
• First received: October 2, 2006
• Last updated: December 4, 2015
• Start date: October 2006
• Est. completion date: June 2010

Study information

• Verified date: December 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Drug:
• Pemetrexed

• Carboplatin

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	Overall response rate = complete response (CR) + partial response (PR) using RECIST.; CR=disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level; PR=at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD	Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)	No
Secondary	Time to Disease Progression	-Progressive disease=at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions	Until patient progresses (median follow-up 293 days -- range (63-632 days)	No
Secondary	Overall Survival Rate		1 year	No
Secondary	Toxicities		30 days following completion of treatment (maximum number of cycles = 6)	Yes
Secondary	Overall Survival Rate		2 years	No
Secondary	Overall Survival (OS)	OS is defined as the time from initiation of treatment to the date of any reason death while those living subjects will be censored at the last assessment date.	Until patient's death (median follow-up 293 days -- range (63-632 days))	No

External Links

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