Pemetrexed, Cisplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

NCT00701857 | Completed Phase 1 DMC

• 6 other identifiers: 07-0612-04P30CA023074UARIZ-07-0612-04UARIZ-BIO07067UARIZ-SRC18084LILLY-UARIZ-07-0612-04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may make tumor cells more sensitive to radiation therapy. Giving pemetrexed together with cisplatin and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when given together with cisplatin and radiation therapy in treating patients with stage III or stage IV esophageal cancer or gastroesophageal junction cancer.

Conditions

Esophageal Cancer

Keywords

stage III esophageal cancer; stage IV esophageal cancer

Outcome Measures

Primary Outcomes (1)

• The maximum tolerated dose (MTD) of pemetrexed

  6 months

Secondary Outcomes (2)

• Toxicity profile

  12 months

• Response (complete response, partial response, progressive disease, and stable disease) as measured by RECIST criteria

  12 months

Study Arms (1)

Pemetrexed, Cisplatin, Radiation Therapy

EXPERIMENTAL

Concomitant Pemetrexed and CDDP Plus Radiation Therapy

Drug: cisplatin; Drug: Pemetrexed; Radiation: radiation therapy

Interventions

cisplatin DRUG

Standard weekly dose

Also known as: CDDP

Pemetrexed, Cisplatin, Radiation Therapy

Pemetrexed DRUG

Biweekly pemetrexed dose escalation

Also known as: Pemetrexed disodium

Pemetrexed, Cisplatin, Radiation Therapy

radiation therapy RADIATION

Weekly standard dose radiation therapy

Also known as: RT

Pemetrexed, Cisplatin, Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• Elquza E, Babiker HM, Howell KJ, Kovoor AI, Brown TD, Patel H, Malangone SA, Borad MJ, Dragovich T. Phase I Study of Concomitant Pemetrexed and Cisplatin Plus External Beam Radiation Therapy in Patients with Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Carcinomas. Cancer Invest. 2016;34(2):57-63. doi: 10.3109/07357907.2015.1108426. Epub 2016 Jan 25.

  PMID: 26810581 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cisplatin; Pemetrexed; Radiotherapy

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; 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; Therapeutics

Study Officials

• Emad Elquza, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2014
• Study Completion: September 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

US (1)