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NCT01202409

CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater

Completed Phase 2 Results posted Last updated 21 February 2020
What this trial tests

Phase 2 trial testing Panitumumab in Gastrointestinal Cancer in 19 participants. Completed in 3 July 2018.

Timeline
2 November 2010
Primary endpoint
3 July 2018
3 July 2018

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment19
Start date2 November 2010
Primary completion3 July 2018
Estimated completion3 July 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Gastrointestinal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Response Rate (RR) Primary · up to 100 weeks

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

GroupValue95% CI
Capecitabine + Panitumumab + Oxaliplatin19
Overall Progression-free Survival (PFS) for CAPOX and Panitumumab Secondary · 7.6 months

Time interval in months from date of first treatment until the date of first documented progression of participants.

GroupValue95% CI
Capecitabine + Panitumumab + Oxaliplatin2.41 – 7.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event collection from date of first treatment to 8 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Capecitabine + Panitumumab + Oxaliplatin
Serious: 2/19 (11%)
Deaths: 19/19

Serious adverse events (2 terms)

ReactionSystemCapecitabine + Panitumumab…
Skin InfectionInfections and infestations
SyncopeNervous system disorders
Other adverse events (46 terms — click to expand)

ReactionSystemCapecitabine + Panitumumab…
Rash acneiformSkin and subcutaneous tissue disorders
HypomagnesemiaMetabolism and nutrition disorders
FatigueGeneral disorders
PruritusSkin and subcutaneous tissue disorders
AnemiaBlood and lymphatic system disorders
AnorexiaMetabolism and nutrition disorders
NauseaGastrointestinal disorders
Peripheral sensory neuropathyNervous system disorders
Alkaline phosphatase increasedInvestigations
HypoalbuminemiaMetabolism and nutrition disorders
Mucositis oralGastrointestinal disorders
Abdominal painGastrointestinal disorders
Alanine Aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
DehydrationMetabolism and nutrition disorders
DiarrheaGastrointestinal disorders
Dry SkinSkin and subcutaneous tissue disorders
HypokalemiaMetabolism and nutrition disorders
Palmmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders
ParonychiaSkin and subcutaneous tissue disorders
Skin and subcutaneous tissue disoreders - OtherSkin and subcutaneous tissue disorders
VomitingGastrointestinal disorders
Weight lossInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
ConstipationGastrointestinal disorders
Dry EyeEye disorders
DysesthesiaNervous system disorders
DysgeusiaNervous system disorders
DyspepsiaGastrointestinal disorders
Edema limbsGeneral disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Eye disorders - otherEye disorders
FallInjury, poisoning and procedural complications
HypocalcemiaMetabolism and nutrition disorders
HypoglycemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
HypophosphatemiaMetabolism and nutrition disorders
HypotensionVascular disorders
Nail infectionSkin and subcutaneous tissue disorders
Oral hemorrhageGastrointestinal disorders

Most-reported serious reactions: Skin Infection, Syncope.

Data from ClinicalTrials.gov NCT01202409 adverse events section.

Sponsor's own description

The goal of this clinical research study is to learn if panitumumab can help to control advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be studied.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Small bowel adenocarcinomas--existing evidence and evolving paradigms.
    Raghav K, Overman MJ. · · 2013 · cited 121× · PMID 23897080 · DOI 10.1038/nrclinonc.2013.132
  2. Trial watch: Chemotherapy with immunogenic cell death inducers.
    Vacchelli E, Galluzzi L, Fridman WH, Galon J, et al · · 2012 · cited 98× · PMID 22720239 · DOI 10.4161/onci.1.2.19026
  3. Phase II Study of Panitumumab in RAS Wild-Type Metastatic Adenocarcinoma of Small Bowel or Ampulla of Vater.
    Gulhati P, Raghav K, Shroff R, Varadhachary G, et al · · 2018 · cited 30× · PMID 29259073 · DOI 10.1634/theoncologist.2017-0568
  4. Small Bowel Adenocarcinoma.
    Chen EY, Vaccaro GM. · · 2018 · cited 17× · PMID 30186048 · DOI 10.1055/s-0038-1660482
  5. Where does chemotherapy stands in the treatment of ampullary carcinoma? A review of literature.
    Ghosn M, Kourie HR, El Rassy E, Haddad FG, et al · · 2016 · cited 17× · PMID 27795814 · DOI 10.4251/wjgo.v8.i10.745
  6. Complete response and prolonged disease-free survival in a patient with recurrent duodenal adenocarcinoma treated with bevacizumab plus FOLFOX6.
    Nagaraj G, Zarbalian Y, Flora K, Tan BR. · · 2014 · cited 5× · PMID 24490045 · DOI 10.3978/j.issn.2078-6891.2013.038

Verify or expand the search:

Other trials of Panitumumab

Trials testing the same drug.

Other recruiting trials for Gastrointestinal Cancer

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01202409.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing