SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00617708

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First-Line Treatment in Patients With Metastatic Pancreatic Cancer

This randomized phase I/II trial is studying the side effects and best dose of monoclonal antibody therapy when given together with gemcitabine hydrochloride and erlotinib hydrochloride and to see how well they work compared with giving gemcitabine hydrochloride and erlotinib hydrochloride alone as first-line therapy in treating patients with metastatic pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving erlotinib hydrochloride and gemcitabine hydrochloride together with monoclonal antibody therapy may kill more tumor cells.

NCT00617708 Stage IV Pancreatic Cancer
MeSH: Pancreatic Neoplasms
HPO: Neoplasm of the pancreas

3 Interventions

Name: cixutumumab

Description: Given IV

Type: Biological

Arm I (erlotinib, gemcitabine, cixutumumab)

Name: erlotinib hydrochloride

Description: Given PO

Type: Drug

Arm I (erlotinib, gemcitabine, cixutumumab) Arm II (erlotinib, gemcitabine)

Name: gemcitabine hydrochloride

Description: Given IV

Type: Drug

Arm I (erlotinib, gemcitabine, cixutumumab) Arm II (erlotinib, gemcitabine)


Primary Outcomes

Description: Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).

Measure: Maximum Tolerated Dose Determination

Time: 28 days

Description: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.

Measure: Progression-Free Survival

Time: Up to 3 years

Secondary Outcomes

Description: From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Measure: Overall Survival

Time: Up to 3 years

Description: Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.

Measure: Response

Time: Up to 3 years

Description: Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Measure: Toxicity

Time: Up to 3 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 P13K

Samples are assessed for the potential relationship between gene expression levels, germline polymorphisms, Ras and P13K mutations and progression-free survival and overall survival. --- P13K ---



HPO Nodes


HPO:
Neoplasm of the pancreas
Genes 80
RAD51 RAD51C CDKN1A PMS1 CDKN1B RAD51D VHL CDKN2A NUTM1 KRAS CDKN2B CDKN2C CDKN2D TGFBR2 FLI1 MRE11 STK11 MSH6 BMPR1A PMS2 MLH3 BRIP1 MGMT SLC12A3 BRCA1 ACD SPINK1 BRCA2 USB1 CLCNKB TINF2 RTEL1 PDGFRB CTC1 PIK3CA NTHL1 BRD4 POT1 MAFA MC1R MITF CHEK2 WT1 APC BARD1 MLH1 PRKAR1A DKC1 NBN COL14A1 RPS20 TSC1 PARN NOP10 TSC2 EWSR1 GCGR MSH2 CDC73 SEMA4A WRAP53 PTEN MDM2 NHP2 TERC AAGAB TERT EPCAM RNF43 PALLD PALB2 TERF2IP TP53 NOTCH3 SMAD4 BAP1 CDK4 MEN1 FAN1 RAD50