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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

October 2, 2006
August 9, 2013
October 2006
November 2009   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00383266 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Neoplasms
  • Drug: Pemetrexed
  • Drug: Carboplatin
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.
Interventions:
  • Drug: Pemetrexed
  • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
June 2010
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00383266
06-0541 / 201103198
Yes
Washington University School of Medicine
Washington University School of Medicine
Eli Lilly and Company
Principal Investigator: Maria Q. Baggstrom, M.D. Washington University School of Medicine
Washington University School of Medicine
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP