Trial Outcomes & Findings for Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma (NCT NCT01182610)

Last Updated: 2012-12-03

Results Overview

The primary endpoint is overall response rate (ORR) as determined per RECIST guidelines version 1.1 from baseline and restaging scans conducted between Days 36 to 43. Response is defined as the occurrence of either Complete Response (CR) or Partial Response (PR) as best response. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of the target lesions taking as reference the baseline sum diameters.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

From the start of study treatment until restaging evaluation performed between days 36 to 43

Results posted on

2012-12-03

Participant Flow

10 sites associated with Accelerated Coummunity Oncology Research Network, Inc. (ACORN) or Georgia Center for Oncology Research and Education (GA-CORE)participated in this study. Enrollment started in May 2011 and was closed in November 2011 due to toxicities observed in a similar trial.

Informed consent was obtained from the subject. The Subject underwent a screening period of up to 35 days during which pre-study assessments were completed.

Participant milestones

Participant milestones
Measure	Treatment Group Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43 Paclitaxel 200mg/m2 on Days 1 and 22 Carboplatin AUC=6 on Days 1 and 22 5FU 225mg/m2/day on Days 1-15 and 22-36
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=1 Participants Panitumumab 9mg/kg on Days 1, 22, and 43 Paclitaxel 200mg/m2 on Days 1 and 22 Carboplatin AUC=6 on Days 1 and 22 5FU 225mg/m2/day on Days 1-15 and 22-36 Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43 Paclitaxel 200mg/m2 on Days 1 and 22 Carboplatin AUC=6 on Days 1 and 22 5FU 225mg/m2/day on Days 1-15 and 22-36
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	73 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of study treatment until restaging evaluation performed between days 36 to 43

Population: This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At time of surgery (between days 50 to 64)

The patient will be scored as having had a pathologic complete response (pCR) if the routine histologic examination of the resected specimen shows no residual invasive cancer by standard hematoxylin and eosin (H\&E) examination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At time of surgery (between days 50 to 64)

The patient will be scored as having an R0 resection, if no invasive cancer is detected involving the margins of the resection by routine microscopic hematoxylin and eosin (H\&E)examination, and the operative report indicates complete resection with no residual disease. The patient will be scored as having an R1 resection, if invasive cancer is detected involving the margins of resection by routine microscopic hematoxylin and eosin (H\&E) examination, and the operative report indicates complete resection with no residual disease. The patient will be scored as having an R2 resection, if the operative report indicates incomplete resection or gross residual disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of surgery to 30 days after date of surgery

All subjects who have undergone surgical resection will be followed for a 30-day postoperative safety evaluation. Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2-year survival from first dose of panitumumab

Outcome measures

Outcome data not reported

Adverse Events

Treatment Group: Panitumumab, Paclitaxel, Carboplatin and 5FU

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group: Panitumumab, Paclitaxel, Carboplatin and 5FU n=1 participants at risk Panitumumab 9mg/kg on Days 1, 22, and 43; Paclitaxel 200mg/m2 on Days 1 and 22; Carboplatin AUC=6 on Days 1 and 22; 5FU 225mg/m2/day on Days 1-15 and 22-36
Blood and lymphatic system disorders Neutropenia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Diarrhoea	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
General disorders Mucosal inflammation	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.

Other adverse events

Other adverse events
Measure	Treatment Group: Panitumumab, Paclitaxel, Carboplatin and 5FU n=1 participants at risk Panitumumab 9mg/kg on Days 1, 22, and 43; Paclitaxel 200mg/m2 on Days 1 and 22; Carboplatin AUC=6 on Days 1 and 22; 5FU 225mg/m2/day on Days 1-15 and 22-36
Blood and lymphatic system disorders Anaemia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Blood and lymphatic system disorders Neutropenia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Blood and lymphatic system disorders Thrombocytopenia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Eye disorders Abnormal sensation in eye	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Abdominal pain	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Diarrhoea	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Dry mouth	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Dysphagia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Nausea	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Stomatitis	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Vomiting	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
General disorders Fatigue	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
General disorders Generalised oedema	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
General disorders Mucosal inflammation	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
General disorders Pyrexia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Investigations Weight Decreased	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Metabolism and nutrition disorders Decreased appetite	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Metabolism and nutrition disorders Hypocalcaemia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Metabolism and nutrition disorders Hypokalaemia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Nervous system disorders Depressed level of consiciousness	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Nervous system disorders Dizziness	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Nervous system disorders Dysgeusia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Nervous system disorders Neuralgia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Nervous system disorders Paraesthesia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Nervous system disorders Syncope	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Psychiatric disorders Anxiety	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Psychiatric disorders Delirium	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Psychiatric disorders Depression	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Psychiatric disorders Insomnia	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Renal and urinary disorders Urinary retention	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Respiratory, thoracic and mediastinal disorders Epistaxis	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Skin and subcutaneous tissue disorders Dermatitis acneiform	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Skin and subcutaneous tissue disorders Exfoliative rash	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.
Vascular disorders Hypotension	100.0% 1/1 • Adverse events collected beginning on day 1 of study treatment through the End of Treatment visit (30 days post-operative, 6 weeks from last treatment administration if treatment failure, or 30 days from last dose of study treatment if early withdrawal). Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.

Additional Information

Vice Presidnet of Scientific Affairs

Accelerated Community Oncology Research Network, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Prior to publication or presentation of Sponsored Research results, Researcher agrees to provide Amgen 60 days to review a manuscript and 15 days to review any poster presentation, abstract or other written or oral materials derived from a Study. If Amgen requests in writing, the Researcher shall withhold material an additional 60 days. Amgen reserves the right to remove confidential information from any publications. The Researcher shall reference Amgen's support of the Study in any material.
Publication restrictions are in place

Restriction type: OTHER