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

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.

Study Overview

• Status: Terminated
• Conditions: Esophageal Neoplasms
• Intervention / Treatment: Drug: Pemetrexed; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Pemetrexed; Drug: Carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Rate		2 years
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)
Overall Survival Rate		1 year
Toxicities		30 days following completion of treatment (maximum number of cycles = 6)
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))

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: October 2, 2006
• First Submitted That Met QC Criteria: October 2, 2006
• First Posted (ESTIMATE): October 3, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): January 11, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Carboplatin; Pemetrexed
• Other Study ID Numbers: 06-0541 / 201103198