- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01182610
Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma
A Phase II Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin and Continuous Infusion 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- Clopton Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Biopsy-proven adenocarcinoma of the distal esophagus, gastroesophageal junction, or proximal stomach (within 5cm of gastroesophageal junction)
- No prior treatment for this disease
- AJCC (American Joint Committee on Cancer) clinical stage II to IVA, potentially resectable disease
- Measurable disease per RECIST 1.0 criteria
- Medically fit for surgery; surgical consultation is encouraged prior to initiation of treatment
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
- Male or female; aged equal to or greater than 18 years
- Life expectancy of greater than 3 months
- Good organ, metabolic, bone marrow, and pulmonary function as specified in the protocol
- Functioning central venous access device prior to treatment initiation
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for at least 6 months following the last administration of panitumumab
- Ability to understand and the willingness to sign a written IRB (Institutional Review Board) approved informed consent
Exclusion Criteria:
- Prior treatment for this disease
- History of another primary cancer except curatively treated in situ cervical cancer, curatively resected nonmelanoma skin cancer, or other primary solid tumor curatively treated with no active disease present and no treatment administered for at least 5 years prior to enrollment
- History or known presence of central nervous system metastases
- History of allergic reactions attributed to compounds similar chemical or biologic composition to panitumumab, paclitaxel, carboplatin, or 5FU
- Prior anti-EGFr-antibody therapy or treatment with small molecule EGFr inhibitors
- Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies within 30 days prior to enrollment
- Chronic use of immunosuppressive agents with the exception of corticosteroids
- Any investigational agent or therapy within 30 days prior to enrollment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- History of interstitial lung disease, e.g., pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan
- History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or investigational product(s) administration or may interfere with the interpretation of the results
- Unwilling or unable to comply with study requirements
- Female who tests positive for serum or urine pregnancy test or is breast feeding
- Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
- Major surgery within 28 days or minor surgery within 7 days prior to treatment. Placement of a central venous access device less than one day prior to treatment start
- Male or female of childbearing potential (women who are post-menopausal less than 52 weeks, not surgically sterilized, or not abstinent) not consenting to use adequate contraception prior to study entry and for at least 6 months following the last administration of panitumumab
- Arterial ischemic event (myocardial infarction, stroke) within 3 months prior to enrollment
- Ongoing therapeutic anticoagulation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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 |
Panitumumab 9mg/kg on Days 1, 22, and 43
Other Names:
Paclitaxel 200mg/m2 on Days 1 and 22
Other Names:
Carboplatin AUC=6 on Days 1 and 22
Other Names:
5FU 225mg/m2/day on Days 1-15 and 22-36
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: From the start of study treatment until restaging evaluation performed between days 36 to 43
|
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.
|
From the start of study treatment until restaging evaluation performed between days 36 to 43
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic Response Rate
Time Frame: At time of surgery (between days 50 to 64)
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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.
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At time of surgery (between days 50 to 64)
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Resection Rate of Surgery
Time Frame: At time of surgery (between days 50 to 64)
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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. |
At time of surgery (between days 50 to 64)
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Thirty-day Surgical Mortality
Time Frame: From date of surgery to 30 days after date of surgery
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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.
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From date of surgery to 30 days after date of surgery
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Survival
Time Frame: 2-year survival from first dose of panitumumab
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2-year survival from first dose of panitumumab
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Hermann, MD, Accelerated Community Oncology Research Network
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Carboplatin
- Paclitaxel
- Fluorouracil
- Panitumumab
Other Study ID Numbers
- ACORN ARCHESO0611
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroesophageal Adenocarcinoma
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Unresectable Gastroesophageal Junction Adenocarcinoma | Locally Advanced Gastroesophageal Junction Adenocarcinoma | Postneoadjuvant Therapy Stage III... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingEsophageal Adenocarcinoma | Esophageal Squamous Cell Carcinoma | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 | Pathologic Stage... and other conditionsUnited States
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Roswell Park Cancer InstitutePfizerRecruitingAdvanced Malignant Solid Neoplasm | Metastatic Colorectal Adenocarcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Clinical Stage III... and other conditionsUnited States
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M.D. Anderson Cancer CenterRecruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States
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Roswell Park Cancer InstituteUnited States Department of DefenseRecruitingClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Locally Advanced Gastroesophageal Junction... and other conditionsUnited States
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NRG OncologyNational Cancer Institute (NCI)RecruitingClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Unresectable Gastroesophageal Junction Adenocarcinoma | Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma... and other conditionsUnited States
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)RecruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedClinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Postneoadjuvant... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage II Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8 | Clinical Stage III Esophageal Adenocarcinoma AJCC v8 | Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8 | Pathologic... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkActive, not recruitingClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8 | Clinical Stage III Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8 | Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8 | Pathologic Stage III Esophageal Adenocarcinoma AJCC v8 and other conditionsUnited States
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Spanish Cooperative Group for the Treatment of...AmgenCompleted
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-
TakedaCompleted
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-
Cliniques universitaires Saint-Luc- Université...Terminated
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Hellenic Cooperative Oncology GroupCompleted
-
University of UtahTerminatedKRAS and NRAS Wild-type Colorectal CancerUnited States
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