A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer - Full Text View

Sponsors and Collaborators:	Washington University School of Medicine Eli Lilly and Company
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00383266

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 II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Carboplatin Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer

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: Every 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the time to disease progression. [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]
To determine the one-year and two-year survival and the overall survival rate for patients with esophageal cancer when treated with pemetrexed and carboplatin. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To determine the toxicities of combination regimen of pemetrexed and carboplatin. [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	43
Study Start Date:	October 2006
Estimated Study Completion Date:	September 2008
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Treatment will consist of pemetrexed through an intravenous (i.v.) injection for 10 minutes, followed by carboplatin through an i.v. injection for 30 minutes. Participants will receive this treatment in the clinic every 3 weeks (one cycle) as long as the disease responds or does not get worse, for a maximum of 6 cycles.	Drug: pemetrexed You will receive pemetrexed through an intravenous (i.v.) injection (through a vein in your hand or arm) for 10 minutes, followed by carboplatin through an i.v. injection for 30 minutes. The treatment with pemetrexed is for research purposes, and is being given because you are taking part in this study. You will receive this treatment in the clinic every 3 weeks (one cycle) as long as your disease responds or does not get worse, for a maximum of 6 cycles. Drug: carboplatin Carboplatin is administered by an intravenous infusion lasting 30 minutes on day 1 every 21 days after the administration of pemetrexed. No pre- or post-treatment hydration or forced diuresis is required.

Arms

Assigned Interventions

1: Experimental

Treatment will consist of pemetrexed through an intravenous (i.v.) injection for 10 minutes, followed by carboplatin through an i.v. injection for 30 minutes. Participants will receive this treatment in the clinic every 3 weeks (one cycle) as long as the disease responds or does not get worse, for a maximum of 6 cycles.

Drug: pemetrexed

You will receive pemetrexed through an intravenous (i.v.) injection (through a vein in your hand or arm) for 10 minutes, followed by carboplatin through an i.v. injection for 30 minutes. The treatment with pemetrexed is for research purposes, and is being given because you are taking part in this study. You will receive this treatment in the clinic every 3 weeks (one cycle) as long as your disease responds or does not get worse, for a maximum of 6 cycles.

Drug: carboplatin

Carboplatin is administered by an intravenous infusion lasting 30 minutes on day 1 every 21 days after the administration of pemetrexed. No pre- or post-treatment hydration or forced diuresis is required.

Detailed Description:

All patients will have the following pre-study evaluations:

complete medical history and physical examination
magnetic resonance imaging (MRI) scan or computed tomography (CT) scan
blood tests (about 3-4 tablespoons of blood will be drawn to conduct standard laboratory tests)

If they are eligible and agree to participate, they will need to take the following premedications:

Folic acid in tablet form (taken at home) once a day beginning approximately 5-7 days before chemotherapy and continuing until 3 weeks after last treatment;
Vitamin B12 as an injection (given in clinic) approximately 1-2 weeks before first chemotherapy treatment and repeated approximately every 9 weeks until 3 weeks after last treatment;
Dexamethasone in tablet form (taken at home) twice daily on the day before, the day of, and the day after each dose of chemotherapy.

Patients will complete a pill diary to monitor compliance with pre-medications.

Treatment will consist of pemetrexed through an intravenous (i.v.) injection for 10 minutes, followed by carboplatin through an i.v. injection for 30 minutes. Participants will receive this treatment in the clinic every 3 weeks (one cycle) as long as the disease responds or does not get worse, for a maximum of 6 cycles.

During treatment, participants will be evaluated every 2 cycles (every 6 weeks) with CT scans and/or MRI scans, to see whether their disease is getting better. In addition, weekly blood will be drawn for safety purposes.

At end of study, the CT or MRI scans and blood tests will be repeated.

We expect that participants will be in the study for approximately 20 weeks (4-5 months.) If the cancer gets worse at any time while they are on the study, participants will be removed from the study and offered other treatment. Once treatment ends, participants will be asked to return to the clinic for blood tests and a physical exam every 2 months for 6 months, then every 3 months for 1 year, and every 6 months thereafter.

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

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

Contacts

Contact: Kristi Williams

314-362-6963

kjwillia1@dom.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
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

Responsible Party:	Washington University School of Medicine ( Maria Baggstrom, M.D. )
Study ID Numbers:	06-0541
Study First Received:	October 2, 2006
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00383266
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Digestive System Neoplasms
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Carboplatin
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009