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Report for Clinical Trial NCT01262482

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2 Trial of Oxaliplatin and Sorafenib Combination in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Relapsed After a Cisplatin Based Treatment

In Spain, the gastric carcinoma is the 5th most frequent malignant tumor in women and the 6th in men, and represents the 3rd cause of cancer-related deaths amongst women and the 4th amongst men. The average of 5-year survival rate in Spain is under 30%. The main reason of it is that, despite carrying out an adjuvant treatment, more than the 50% will present relapsed disease. Sorafenib has been the first RAF inhibitor, both of RAF-1 and B-rRAF and its b-RAF variant V600E. Moreover, it has shown its ability to inhibit other tyrosin-quinase receptors as VEGFR 2 and 3, c-kit, Flt-3 or PDGFR. Its activity has been clearly proven in clear cell renal carcinoma. The mechanism by which Sorafenib seems to act is not because of the existence of a mutation of RAS or RAF, but because as there is a VHL shortage the HIP produces a VEGF, bFGF or TGF overexpression that produces in turn a hyper-stimulation on the RAF/ERK/MEK pathway. The RAF/MEK/ERK pathway and angiogenesis seem to be clearly involved in the gastric carcinoma tumorigenesis and progression. Because of that, it seems interesting to associate Sorafenib to an oxaliplatin-based chemotherapy, which has shown its effectiveness in relapsed patients after receiving cisplatin-based schemes. Moreover, there is a phase 1 trial confirming the tolerance of the oxaliplatin and Sorafenib association, describing partial responses amongst gastric cancer patients previously treated with cisplatin.

NCT01262482 Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Relapsed After a Cisplatin Based Treatment)
MeSH: Adenocarcinoma Esophageal Neoplasms
HPO: Esophageal neoplasm

2 Interventions

Name: Oxaliplatin

Description: 130 mg/m2, IV during 2 hours on day 1 of each 21 day cycle. Number of cycles: until progression, intolerance or unacceptable toxicity develops, or until patient or investigator decide to stop the treatment.

Type: Drug

Oxaliplatin + Sorafenib

Name: Sorafenib

Description: 400mg, orally, 2 times per day. Until progression, intolerance or unacceptable toxicity develops, or until patient or investigator decide to stop the treatment.

Type: Drug

Oxaliplatin + Sorafenib


Primary Outcomes

Description: Measurements according to RECIST criteria (Response Evaluation Criteria in Solid Tumors). Main techniques: CT-scan and Magnetic Resonance Imaging (MRI)

Measure: Progression free survival

Time: anticipated 3 years

Secondary Outcomes

Description: Measurements according to RECIST criteria (Response Evaluation Criteria in Solid Tumors). Main techniques: CT-scan and Magnetic Resonance Imaging (MRI)

Measure: Tumoral response

Time: anticipated 3 years

Description: Duration of the partial or total response to the treatment. Evaluation and classification according to RECIST criteria (Response Evaluation Criteria in Solid Tumors)

Measure: Response duration

Time: anticipated 3 years

Measure: Overall survival

Time: anticipated 3 years

Measure: Toxicity

Time: anticipated 3 years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 V600E

Sorafenib has been the first RAF inhibitor, both of RAF-1 and B-rRAF and its b-RAF variant V600E. --- V600E ---



HPO Nodes


HPO:
Esophageal neoplasm
Genes 21
RHBDF2 PDGFRA FH KIT RAD21 CTHRC1 DLEC1 WWOX STK11 ASCC1 TGFBR2 SDHB KIT RNF6 APC SDHA SDHC RHBDF2 STAT1 MSR1 APC