Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroeso… (NCT01182610) | Clinical Trial Compass
TerminatedPhase 2
Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma
Stopped: Safety concern in a similar trial enrolling the same patient population
United States1 participantsStarted 2011-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Response Rate
Timeframe: From the start of study treatment until restaging evaluation performed between days 36 to 43
Trial details
NCT IDNCT01182610
SponsorAccelerated Community Oncology Research Network