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Report for Clinical Trial NCT00617708

Developed by Shray Alag, 2020.
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 105
MGMT BRCA1 MLH1 PMS2 RAD51C TERC CDKN2B PALLD TSC2 CHEK2 SMAD4 NTHL1 RAD51D CTC1 MSH6 NOP10 KRAS NHP2 BAP1 PDGFRB FAN1 KRAS BRD4 RNF43 CDKN2B TP53 MSH2 CDKN2A SPINK1 RTEL1 CDKN2C VHL PIK3CA CDK4 PARN BRCA2 KRAS TERF2IP CHEK2 CDKN1A RPS20 BRCA1 USB1 PRKAR1A POT1 TERT APC CDKN2A CCND1 STK11 TP53 COL14A1 NUTM1 MDM2 TSC1 BRCA2 SLC12A3 EWSR1 CDC73 CDKN1B ACD CDC73 BRIP1 MRE11 GCGR TP53 STK11 EPCAM MEN1 NPM1 WRAP53 TGFBR2 SEMA4A TINF2 MITF BMPR1A TP53 NOTCH3 DKC1 BARD1 AAGAB SMAD4 RAD50 STK11 NBN MLH3 PALB2 PALB2 CDKN2A WT1 BRCA2 MAFA MC1R MEN1 RAD51 CDC73 CLCNKB TP53 CDKN1B FLI1 PTEN PMS1 CDKN2A TERT APC