A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Pemetrexed
- Conditions
- Esophageal Neoplasms
- Sponsor
- Washington University School of Medicine
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Overall Response Rate (ORR)
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
- •Pleural/pericardial effusion
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
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
- •Patients with known active CNS metastases.
Arms & Interventions
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.
Intervention: Pemetrexed
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.
Intervention: Carboplatin
Outcomes
Primary Outcomes
Overall Response Rate (ORR)
Time Frame: Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)
* 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
Secondary Outcomes
- Time to Disease Progression(Until patient progresses (median follow-up 293 days -- range (63-632 days))
- Overall Survival Rate(2 years)
- Toxicities(30 days following completion of treatment (maximum number of cycles = 6))
- Overall Survival (OS)(Until patient's death (median follow-up 293 days -- range (63-632 days)))