Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma
This study has been terminated.
(Safety concern in a similar trial enrolling the same patient population)
Sponsor:
Accelerated Community Oncology Research Network
Collaborator:
Amgen
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:
NCT01182610
First received: August 13, 2010
Last updated: March 27, 2012
Last verified: March 2012
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Purpose
This is an open-label, Phase II, single-stage study evaluating the use of panitumumab, paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal adenocarcinoma. The expectation is that this combination will both increase potential overall survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease potential surgical mortality by eliminating pre-operative radiation therapy.
Condition | Intervention | Phase |
---|---|---|
Gastroesophageal Adenocarcinoma Adenocarcinoma of the Distal Esophagus Adenocarcinomas of the Gastroesophageal Junction Adenocarcinoma of the Proximal Stomach |
Drug: panitumumab, paclitaxel, carboplatin, and continuous infusion 5FU |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Phase II Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin and Continuous Infusion 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma |
Resource links provided by NLM:
Further study details as provided by Accelerated Community Oncology Research Network:
Primary Outcome Measures:
- Response rate [ Time Frame: From the start of study treatment until restaging evaluation performed between days 36 to 43 ] [ Designated as safety issue: No ]Efficacy will be evaluated by response rate as measured by RECIST version 1.0
Secondary Outcome Measures:
- Pathologic response rate [ Time Frame: At time of surgery (between days 50 to 64) ] [ Designated as safety issue: No ]
- Resection rate of surgery [ Time Frame: At time of surgery (between days 50 to 64) ] [ Designated as safety issue: No ]
- Thirty-day surgical mortality [ Time Frame: From date of surgery to 30 days after date of surgery ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 2-year survival from first dose of panitumumab ] [ Designated as safety issue: No ]
Enrollment: | 1 |
Study Start Date: | April 2011 |
Study Completion Date: | March 2012 |
Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: panitumumab, paclitaxel, carboplatin, and continuous infusion 5FU
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
Other Name: Vectibix
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182610
Locations
United States, Arkansas | |
Clopton Clinic | |
Jonesboro, Arkansas, United States, 72401 |
Sponsors and Collaborators
Accelerated Community Oncology Research Network
Amgen
Investigators
Principal Investigator: | Robert Hermann, MD | Accelerated Community Oncology Research Network |
More Information
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
Responsible Party: | Accelerated Community Oncology Research Network |
ClinicalTrials.gov Identifier: | NCT01182610 History of Changes |
Other Study ID Numbers: | ACORN ARCHESO0611 |
Study First Received: | August 13, 2010 |
Last Updated: | March 27, 2012 |
Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Additional relevant MeSH terms:
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Fluorouracil Carboplatin Paclitaxel Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on October 17, 2012