Individualized Drug Treatment for Treating Patients With Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT00276744
• Recruitment Status: Terminated
• First Posted: January 13, 2006
• Results First Posted: August 27, 2018
• Last Update Posted: October 24, 2018
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Cancer
• Interventions: Biological: cetuximab; Drug: capecitabine; Drug: docetaxel; Drug: Erlotinib; Drug: Gemcitabine; Drug: Irinotecan; Drug: mitomycin C; Drug: rapamycin; Procedure: conventional surgery
• Enrollment: 249

Participant Flow

Recruitment Details
Pre-assignment Details	249 participants were enrolled however 240 received intervention in the study. Reason unknown and data is not accessible for the 9 remaining participants who were not assigned to intervention

Arm/Group Title	Arm 1
Arm/Group Description	PART A: Participants will have their tumors collected at the time of conventional surgery. Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Patients will then proceed to receive adjuvant treatment based on physician discretion and will be followed until disease progression. Capecitabine 1,5 mmol/kg Oral gavage 1- 5 days x 2 weeks Cetuximab 500 mg IP Twice a week x 2 weeks Docetaxel 20 mg/kg IV Once at week x 4 weeks Erlotinib 75 mg/kg IP 1-5 days x 2 weeks Gemcitabine 100 mg/kg IP Twice a week x 4 weeks Irinotecan 50 mg/kg IV Twice a week Mitomycin C 5 mg/kg IP One dose Rapamycin 4 mg/kg IP 1-5 days x 2 weeks PART B: At the time of progression, patients will be evaluated for Part B of the study and treated with the drug selected in Part A as the most active using approved doses and schedules of administration.
Period Title: PART A
Started	240
Completed	142
Not Completed	98
Reason Not Completed
Reason unknown	98
Period Title: PART B
Started	0 [1]
Completed	0
Not Completed	0
[1] This study was terminated before participants could reach this stage of the study.

Baseline Characteristics

Arm/Group Title		Arm 1
Arm/Group Description		PART A: Participants will have their tumors collected at the time of conventional surgery. Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Patients will then proceed to receive adjuvant treatment based on physician discretion and will be followed until disease progression. Capecitabine 1,5 mmol/kg Oral gavage 1- 5 days x 2 weeks Cetuximab 500 mg IP Twice a week x 2 weeks Docetaxel 20 mg/kg IV Once at week x 4 weeks Erlotinib 75 mg/kg IP 1-5 days x 2 weeks Gemcitabine 100 mg/kg IP Twice a week x 4 weeks Irinotecan 50 mg/kg IV Twice a week Mitomycin C 5 mg/kg IP One dose Rapamycin 4 mg/kg IP 1-5 days x 2 weeks PART B: At the time of progression, patients will be evaluated for Part B of the study and treated with the drug selected in Part A as the most active using approved doses and schedules of administration.
Overall Number of Baseline Participants		240
Baseline Analysis Population Description		Study was terminated before participants could be entered into Part B.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	240 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	187 77.9%
	>=65 years	53 22.1%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	240 participants
	Female	115 47.9%
	Male	125 52.1%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	240 participants
		240

Outcome Measures

1. Primary Outcome

Title	6-month Overall Survival
Description	Percentage of patients survived at 6 months for patients whose tumors were xenografted and treated in the mouse when treated with the most active agent identified in that model
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description:	PART A: Participants will have their tumors collected at the time of conventional surgery. Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Patients will then proceed to receive adjuvant treatment based on physician discretion and will be followed until disease progression. Capecitabine 1,5 mmol/kg Oral gavage 1- 5 days x 2 weeks Cetuximab 500 mg IP Twice a week x 2 weeks Docetaxel 20 mg/kg IV Once at week x 4 weeks Erlotinib 75 mg/kg IP 1-5 days x 2 weeks Gemcitabine 100 mg/kg IP Twice a week x 4 weeks Irinotecan 50 mg/kg IV Twice a week Mitomycin C 5 mg/kg IP One dose Rapamycin 4 mg/kg IP 1-5 days x 2 weeks PART B: At the time of progression, patients will be evaluated for Part B of the study and treated with the drug selected in Part A as the most active using approved doses and schedules of administration.
Overall Number of Participants Analyzed	236
Measure Type: Number; Unit of Measure: percentage of participants
	53

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	The patients all received FDA approved chemotherapy depending on the results in their mice, so adverse events were not monitored or assessed. Therefore adverse event data was not collected.
Arm/Group Title	Arm 1
Arm/Group Description	PART A: Participants will have their tumors collected at the time of conventional surgery. Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Patients will then proceed to receive adjuvant treatment based on physician discretion and will be followed until disease progression. Capecitabine 1,5 mmol/kg Oral gavage 1- 5 days x 2 weeks Cetuximab 500 mg IP Twice a week x 2 weeks Docetaxel 20 mg/kg IV Once at week x 4 weeks Erlotinib 75 mg/kg IP 1-5 days x 2 weeks Gemcitabine 100 mg/kg IP Twice a week x 4 weeks Irinotecan 50 mg/kg IV Twice a week Mitomycin C 5 mg/kg IP One dose Rapamycin 4 mg/kg IP 1-5 days x 2 weeks PART B: At the time of progression, patients will be evaluated for Part B of the study and treated with the drug selected in Part A as the most active using approved doses and schedules of administration.
All-Cause Mortality
	Arm 1
	Affected / at Risk (%)
Total	0/0
Serious Adverse Events
	Arm 1
	Affected / at Risk (%)
Total	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm 1
	Affected / at Risk (%)
Total	0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Daniel Laheru
• Organization: SKCCC
• Phone: 410-955-8974
• EMail: laherda@jhmi.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Villarroel MC, Rajeshkumar NV, Garrido-Laguna I, De Jesus-Acosta A, Jones S, Maitra A, Hruban RH, Eshleman JR, Klein A, Laheru D, Donehower R, Hidalgo M. Personalizing cancer treatment in the age of global genomic analyses: PALB2 gene mutations and the response to DNA damaging agents in pancreatic cancer. Mol Cancer Ther. 2011 Jan;10(1):3-8. doi: 10.1158/1535-7163.MCT-10-0893. Epub 2010 Dec 6.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT00276744
• Other Study ID Numbers: J0507; P30CA006973 ( U.S. NIH Grant/Contract ); CDR0000455000; 05-04-14-02 ( Other Identifier: JHM IRB )
• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Results First Submitted: February 27, 2018
• Results First Posted: August 27, 2018
• Last Update Posted: October 24, 2018