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

This study has been terminated.
(Low accrual)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00383266
First received: October 2, 2006
Last updated: December 4, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Esophageal Neoplasms
Drug: Pemetrexed
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Until patient progresses or dies (median follow-up 293 days -- range (63-632 days) ] [ Designated as safety issue: No ]
    • 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 Outcome Measures:
  • Time to Disease Progression [ Time Frame: Until patient progresses (median follow-up 293 days -- range (63-632 days) ] [ Designated as safety issue: No ]
    -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

  • Overall Survival Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicities [ Time Frame: 30 days following completion of treatment (maximum number of cycles = 6) ] [ Designated as safety issue: Yes ]
  • Overall Survival Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Until patient's death (median follow-up 293 days -- range (63-632 days)) ] [ Designated as safety issue: No ]
    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.


Enrollment: 9
Study Start Date: October 2006
Study Completion Date: June 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383266

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Eli Lilly and Company
Investigators
Principal Investigator: Maria Q. Baggstrom, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00383266     History of Changes
Other Study ID Numbers: 06-0541 / 201103198 
Study First Received: October 2, 2006
Results First Received: October 20, 2015
Last Updated: December 4, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 26, 2016