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Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT01128387
Recruitment Status : Terminated (slow accrual)
First Posted : May 21, 2010
Results First Posted : January 23, 2018
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
University of Wisconsin, Madison

May 17, 2010
May 21, 2010
November 8, 2017
January 23, 2018
March 14, 2018
May 2010
October 2016   (Final data collection date for primary outcome measure)
MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT [ Time Frame: approximately 18 weeks ]
Maximum Tolerated Dose (MTD) will be where 0 of 6 patients experienced Dose Limiting Toxicities (DLT) from start until 28 days after the completion of radiation. The investigator considered DLTs related to the treatment to be: grade 4 hematologic toxicity, grade 3 hematologic toxicity lasting >7 days, any neutropenic fever, all grade 3 non-hematologic toxicities (excluding alopecia and nausea/vomiting/diarrhea if controlled with antiemetics or anti-diarrheal agents), grade 4 lab abnormality (whether symptomatic or asymptomatic), any treatment related to death, any toxicity associated with 1) any single interruption of radiation >10 treatment days, 2) >2 interruptions of radiation per course, 3) a delay in completion of radiation by >14 days beyond planned treatment schedule, 4) inability to deliver >80% of planned treatment doses, 5) any infield grade 4 toxicity
MTD of panitumumab in combination with Cisplatin/fluorouracil and radiation for locally advanced esophageal cancer [ Time Frame: approximately 18-20 weeks ]
From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post XRT/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
Complete list of historical versions of study NCT01128387 on ClinicalTrials.gov Archive Site
Pathologic Response [ Time Frame: 20 weeks. ]
From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post Radiation (XRT)/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
Pathologic Response [ Time Frame: approximately 18-20 weeks. ]
From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post XRT/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
Not Provided
Not Provided
 
Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer
A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer

The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET (Positron Emission Tomography) imaging to predict the degree of pathologic response.

All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Dose escalation study
Masking: None (Open Label)
Primary Purpose: Treatment
Cancer
Drug: Panitumumab
dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.
  • Experimental: Dose Level -1
    Panitumumab/Cisplatin/Fluorouracil and Radiation therapy 1.5mg/kg Panitumumab, 60mg/m2 cisplatin, 750mg/m2 5FU (Fluorouracil)
    Intervention: Drug: Panitumumab
  • Experimental: Dose Level 1
    Panitumumab/Cisplatin/Fluorouracil and Radiation therapy 1.5mg/kg Panitumumab, 80mg/m2 cisplatin, 1000mg/m2 5FU (Fluorouracil)
    Intervention: Drug: Panitumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
36
October 2016
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Locally Advanced Esophageal cancer (stages T1N1 or T2-4 any N)
  2. Histology must be adenocarcinoma or squamous cell carcinoma
  3. Must be surgical candidate based on evaluation by a thoracic surgeon
  4. must have adequate organ function as defined by routine lab tests

Exclusion Criteria:

  1. Insitu carcinoma
  2. prior chemotherapy for esophageal cancer
  3. Metastatic (stage IV disease)
  4. Tumors <5cm from the cricopharyngeus muscle, Tumors with >75% of tumor located within the stomach
  5. Active, uncontrolled cardiac disease
  6. subjects with >Grade 2 neuropathies. -
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01128387
H-2009-0214
RO09211 ( Other Identifier: UWCCC )
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Amgen
Not Provided
University of Wisconsin, Madison
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP