Know Cancer

or
forgot password

PHASE I STUDY OF CONCOMITANT PEMETREXED AND CDDP PLUS RADIATION THERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ESOPHAGEAL OR GASTROESOPHAGEAL (GEJ) CARCINOMAS


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

Thank you

Trial Information

PHASE I STUDY OF CONCOMITANT PEMETREXED AND CDDP PLUS RADIATION THERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ESOPHAGEAL OR GASTROESOPHAGEAL (GEJ) CARCINOMAS


OBJECTIVES:

Primary

- To establish the maximum tolerated dose of pemetrexed disodium in combination with
cisplatin and standard-dose radiotherapy in patients with stage III or IV esophageal or
gastroesophageal junction carcinoma.

Secondary

- To specifically characterize the toxicity profile of this regimen.

- To investigate, preliminarily, the anti-tumor activity of this regimen, as measured by
standard response criteria (RECIST criteria), in patients with measurable disease.

OUTLINE: This is a dose-escalation study of pemetrexed disodium.

Patients receive pemetrexed disodium IV over 10 minutes on days 1, 15, and 29 and cisplatin
IV over 10 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external beam
radiotherapy once daily, 5 days a week, for up to 6 weeks.

After completion of study therapy, patients are followed for 30 days and then every 3 months
for 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of esophageal or gastroesophageal junction carcinoma

- Stage III or IV disease

- Treatment with chemoradiotherapy is considered appropriate

- Measurable or evaluable disease

- Clinically significant pleural or pericardial effusions or ascites allowed provided
they were drained prior to study entry

- No pleurodesis within the past 2 weeks

- Controlled brain metastasis allowed provided patient is clinically stable with no
signs of progression by MRI or CT scan of the brain ≥ 60 days after completion of
treatment AND is asymptomatic and does not require steroids

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- WBC ≥ 2,500/mm^3

- ANC ≥ 1,500/mm^3

- Hemoglobin ≥ 9 g/dL

- Platelet count ≥ 100,000/mm^3

- Total bilirubin normal

- Alkaline phosphatase AND AST and ALT meeting the following criteria:

- Alkaline phosphatase normal AND AST or ALT ≤ 3 times upper limit of normal (ULN)
(≤ 5 times ULN for patients with liver metastases)

- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal

- Creatinine clearance ≥ 45 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study therapy

- Able to take folic acid, vitamin B_12, or corticosteroids

- No known severe hypersensitivity reaction to study drugs

- No uncontrolled serious active infection

- No pre-existing peripheral neuropathy > grade 1

- No significant cardiac disease, including any of the following:

- Uncontrolled high blood pressure

- Unstable angina

- Congestive heart failure within the past 6 months

- Left ventricular ejection fraction below the lower limit of normal

- Myocardial infarction within the past year

- Serious cardiac arrhythmias requiring medication

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior systemic therapy regimens

- No prior radiotherapy to gastric/esophageal fields

- No aspirin or other NSAID before and after pemetrexed disodium administration

- No concurrent colony-stimulating factors (CSF) to maintain WBC and ANC eligibility
values

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The maximum tolerated dose (MTD) of pemetrexed

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Emad Elquza, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

07-0612-04

NCT ID:

NCT00701857

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

University of Arizona Cancer CenterTucson, Arizona  85724