Trial Outcomes & Findings for Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma (NCT NCT00430027)

Last Updated: 2013-12-12

Results Overview

The primary objective of this pilot study was to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab is feasible with acceptable toxicity profile.

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

Up to 4 weeks

Results posted on

2013-12-12

Participant Flow

Between November 2006 and August 2008, 8 patients were enrolled in the study from the Radiation Oncology clinic.

This was to be a pilot/feasibility trial with a maximum of 15 patients enrolled, with the intent to propose a phase II trial. The study stopped before enrolling 15 patients, therefore the phase II trial was not pursued.

Participant milestones

Participant milestones
Measure	Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
Overall Study Study terminated	8

Baseline Characteristics

Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy n=8 Participants Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	64.0 years STANDARD_DEVIATION 10.28 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Population: The study was terminated, study end points were not reached.

Outcome measures

Outcome data not reported

Adverse Events

Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy n=8 participants at risk Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
Infections and infestations Infection	12.5% 1/8 • Number of events 1 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.

Other adverse events

Other adverse events
Measure	Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy n=8 participants at risk Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 2 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 2 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Metabolism and nutrition disorders Anorexia	25.0% 2/8 • Number of events 2 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Metabolism and nutrition disorders Dehydration	25.0% 2/8 • Number of events 3 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Gastrointestinal disorders Dysphagia	12.5% 1/8 • Number of events 2 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Gastrointestinal disorders Distension	12.5% 1/8 • Number of events 1 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Metabolism and nutrition disorders Hyperglycemia	25.0% 2/8 • Number of events 2 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Blood and lymphatic system disorders Lymphopenia	75.0% 6/8 • Number of events 21 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Investigations INR	37.5% 3/8 • Number of events 11 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Immune system disorders Hypersensitivity	25.0% 2/8 • Number of events 2 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 1/8 • Number of events 1 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Metabolism and nutrition disorders Hyponatremia	12.5% 1/8 • Number of events 1 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
General disorders Fatigue	12.5% 1/8 • Number of events 1 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
General disorders Pain	12.5% 1/8 • Number of events 1 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Metabolism and nutrition disorders Hypophosphatemia	25.0% 2/8 • Number of events 4 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Cardiac disorders Pericardial effusion	12.5% 1/8 • Number of events 1 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Cardiac disorders Atrial fibrillation	12.5% 1/8 • Number of events 1 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 1/8 • Number of events 1 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.
Renal and urinary disorders Renal failure	12.5% 1/8 • Number of events 1 • Participants were monitored for approximately 2 years. Patients were assessed weekly at their clinic visits.

Additional Information

Dr. Tracey Schefter

University of Colorado, Denver

Phone: 720-848-0100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place