Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer

NCT00578071 | Completed Phase 1 Results

• 2 other identifiers: Pro00002207SPS 151596
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of panitumumab, oxaliplatin and capecitabine in patients undergoing radiation therapy for carcinoma of the thoracic esophagus or gastroesophageal junction. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.

Conditions

Cancer of the Esophagus

Keywords

esophageal cancer

Outcome Measures

Primary Outcomes (2)

• Panitumumab Maximum Tolerated Dose in Milligrams (mg)

  60 days

• Number of Participants With Dose-limiting Toxicities (DLTs)

  Within 30 days of the last day of radiation

Secondary Outcomes (2)

• Overall Survival Rates for the Patients Studied on This Protocol.

  One year

• Pathological Complete Response Rates Associated With This Regimen.

  90 days

Study Arms (1)

Treatment

EXPERIMENTAL

panitumumab, oxaliplatin, capecitabine and EBRT

Drug: Panitumumab; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiation Therapy (RT)

Interventions

Panitumumab DRUG

Dose per cohort level (3.6, 4.8 or 6.0 mg/kg ), given intravenously (IV) days 1, 15 and 29 of radiation.

Treatment

Capecitabine DRUG

Dose per cohort level (500, 625 or 825 mg/m2) taken by mouth twice each day of radiation

Also known as: Xeloda

Treatment

Oxaliplatin DRUG

Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiation

Treatment

Radiation Therapy (RT) RADIATION

Daily for 6 weeks

Treatment

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Histologically or cytologically documented squamous cell carcinoma or Siewert's classification adenocarcinoma of the esophagus or proximal stomach T1-4, N0-2, M0-1, for which bimodality treatment with chemotherapy and radiation therapy is indicated.
• Measurable Disease
• ECOG Performance Status 0-1
• Laboratory values must be as follows:
• Absolute neutrophil count \> or = 2,000/mm3,
• Platelets \> or = 100,000/mm3,
• Hemoglobin \> 9.0,
• Total bilirubin \<1.5 x institutional upper normal limit,
• Serum creatinine \<1.5 x institutional upper normal limit,
• AST or ALT \< 3x institutional upper normal limit,
• Magnesium equal or higher than institutional lower limit,
• Creatinine clearance Estimated \> 40 ml/min,
• Calcium \> lower limit of normal.
• Not pregnant or lactating. Negative pregnancy test within 72 hours prior to registration (female patients of childbearing potential). Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.

You may not qualify if:

• Tumors extending above the level of the thoracic inlet or beyond 5 cm below the gastroesophageal junction.
• Patients with radiographic or bronchoscopic evidence of esophageal perforation.
• Patients with known evidence of brain metastases, lymphangitic lung metastases, or carcinomatous meningitis.
• Dementia or significantly altered mental status
• Major surgery within 4 weeks of the start of study treatment
• Prior chemotherapy, radiation therapy, hormonal or biologic therapy within the past 6 months.
• Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine, corticosteroids)
• Currently requiring medications that may interact with the metabolism or disposition of capecitabine/5-FU: dipyridamole, folinic acid, allopurinol, trimethoprim, misonidazole, metoclopramide, flucytosine or cimetidine.
• Hypersensitivity to platinum containing compounds or capecitabine or any of the excipients of this product. Prior unanticipated severe reaction to fluoropyrimidine/platinum therapy, or known sensitivity to 5-fluorouracil/platinum containing compounds.
• Serious, uncontrolled, concurrent infection(s).
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
• Peripheral neuropathy \> grade 1
• Any of the following within 24 weeks before randomization: clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia).
• Uncontrolled gastrointestinal ulcer within 28 days of randomization

Sponsors & Collaborators

• Brian Czito: lead
• Amgen: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

• Clinical Trials at Duke Comprehensive Cancer Center

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Panitumumab; Capecitabine; Oxaliplatin; 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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Therapeutics

Results Point of Contact

• Title: Dr Brian Czito
• Organization: Duke University Medical Center Radiation Oncology

brian.czito@duke.edu

668-7336

Study Officials

• Brian Czito, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Radiation Oncology

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: December 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: June 1, 2012
• Last Updated: July 2, 2015
• Results First Posted: August 7, 2012

Record last verified: 2015-05

Locations

US (1)