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: August 9, 2013
Last verified: August 2013
  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: Allocation: Non-Randomized
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:
  • To determine response rates in patients with esophageal cancer when treated with pemetrexed and carboplatin [ Time Frame: Until patient progresses or dies ] [ Designated as safety issue: No ]
    Every 2 cycles during treatment. If complete response, partial response or stable disease every 2 months for 1st 6 months following end of treatment, then every 3 months for the next year, and then every 6 months thereafter.


Secondary Outcome Measures:
  • To determine the time to disease progression. [ Time Frame: Until patient progresses ] [ Designated as safety issue: No ]
    Every 2 cycles during treatment. If complete response, partial response or stable disease every 2 months for 1st 6 months following end of treatment, then every 3 months for the next year, and then every 6 months thereafter.

  • To determine the one-year survival rate for patients with esophageal cancer when treated with pemetrexed and carboplatin. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To determine the toxicities of combination regimen of pemetrexed and carboplatin. [ Time Frame: 30 days following completion of treatment ] [ Designated as safety issue: Yes ]
  • To determine the two-year survival rate for patients with esophageal cancer when treated with pemetrexed and carboplatin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the overall survival rate for patients with esophageal cancer when treated with pemetrexed and carboplatin. [ Time Frame: Until patient's death ] [ Designated as safety issue: No ]

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/m2 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
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/mm3, absolute neutrophil count (ANC) >= 1,500/mm3, hemoglobin >= 9.0 g/dL, and platelet count >= 100,000/mm3.
  • 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:
No publications provided

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
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pemetrexed
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 21, 2014