Panitumumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Advanced Esophageal or Gastroesophageal Junction Cancer
|ClinicalTrials.gov Identifier: NCT01307956|
Recruitment Status : Unknown
Verified July 2011 by University of Nebraska.
Recruitment status was: Recruiting
First Posted : March 3, 2011
Last Update Posted : July 13, 2011
RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, 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. Giving monoclonal antibody therapy together with chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving panitumumab, combination chemotherapy, and radiation therapy together before surgery works in treating patients with advanced esophageal or gastroesophageal (GE) junction cancer
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Esophagus Adenocarcinoma of the Gastroesophageal Junction Stage II Esophageal Cancer||Biological: panitumumab Drug: oxaliplatin Drug: leucovorin calcium Drug: fluorouracil Radiation: radiation therapy Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis Other: high performance liquid chromatography Genetic: DNA analysis Genetic: polymorphism analysis Other: pharmacological study Other: pharmacogenomic studies||Phase 2|
I. To determine the pathologic complete response rate of a modified FOLFOX-6 regimen (leucovorin calcium, fluorouracil, and oxaliplatin) given with panitumumab at two-week intervals x 4 cycles in combination with external beam radiation therapy for patients with locally advanced adenocarcinoma of the esophagus.
I. To determine the toxicities and ability to complete the planned treatment. II. To determine the achieved steady-state plasma concentrations of 5-FU (fluorouracil) and correlate these with clinical toxicity.
III. To assess the potential importance of polymorphic variations in genomic deoxyribonucleic acid (DNA) of pertinent genes whose protein products are the targets of the anti-neoplastic drugs used in the clinical protocol on response and toxicity to therapy.
Patients receive panitumumab intravenously (IV) over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of chemotherapy and radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy.
After completion of study treatment, patients are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Neo-Adjuvant Therapy With Oxaliplatin, Leucovorin, 5-Fluorouracil, Panitumumab (Vectibix) and Radiation in Patients With Locally Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||October 2015|
Experimental: Treatment (monoclonal antibody, chemotherapy, radiation)
Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of chemotherapy and radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy.
Other Names:Drug: oxaliplatin
Other Names:Drug: leucovorin calcium
Other Names:Drug: fluorouracil
Other Names:Radiation: radiation therapy
Undergo radiation therapy
Other Names:Procedure: therapeutic conventional surgery
Undergo surgical resectionOther: laboratory biomarker analysis
Correlative studiesOther: high performance liquid chromatography
Other Name: HPLCGenetic: DNA analysis
Correlative studiesGenetic: polymorphism analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studiesOther: pharmacogenomic studies
Other Name: Pharmacogenomic Study
- Complete pathological response (pCR) rate [ Time Frame: After 4 courses of protocol therapy ]Based on the proportion who achieve pCR. Evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines.
- Proportion of patients who can undergo resection [ Time Frame: Four weeks after completion of the chemo-radiation ]
- Survival [ Time Frame: From the first date of therapy until the date the patient dies ]
- Time to treatment failure [ Time Frame: From the first date of therapy until the date the patient is removed from study for any reason ]
- Steady-state plasma concentrations of 5-FU [ Time Frame: Pre-treatment and at hours 22, 23, 43, and 44 hours during the 46-hr infusion week 1 ]
- Polymorphic variations in genomic DNA [ Time Frame: At baseline (pre-treatment) and every 4 weeks only if initially elevated ]
- Incidence of adverse events [ Time Frame: When reported by patients, and at physical examinations every 2 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307956
|Contact: Mary "Beth" Kos, RN BSN OCNemail@example.com|
|Contact: Marsha Ketcham, RN OCNfirstname.lastname@example.org|
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198-6805|
|Contact: Jean L. Grem 402-559-6210 email@example.com|
|Principal Investigator: Jean L. Grem|
|Principal Investigator:||Jean Grem||University of Nebraska|