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

NCT00383266 | Terminated Phase 2 Results DMC

• 1 other identifier: 06-0541 / 201103198
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to Disease Progression

  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 Rate

  2 years

• Overall Survival (OS)

  Until patient's death (median follow-up 293 days -- range (63-632 days))

Study Arms (1)

Pemetrexed + Carboplatin

EXPERIMENTAL

* 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

Interventions

Pemetrexed DRUG

Pemetrexed + Carboplatin

Carboplatin DRUG

Pemetrexed + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Limitations and Caveats

The study was terminated due to lack of participant accrual.

Results Point of Contact

• Title: Maria Baggstrom, M.D.
• Organization: Washington University School of Medicine

mbaggstr@dom.wustl.edu

314-362-5740

Study Officials

• Maria Q. Baggstrom, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2006
• First Posted: October 3, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: June 1, 2010
• Last Updated: January 11, 2016
• Results First Posted: January 11, 2016

Record last verified: 2015-12

Locations

US (1)