Individualized Drug Treatment for Treating Patients With Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT00276744 |
Recruitment Status :
Terminated
(Because there was no longer an active laboratory component to this study.)
First Posted : January 13, 2006
Results First Posted : August 27, 2018
Last Update Posted : October 24, 2018
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Study Type | Interventional |
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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 |
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 |
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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.
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Arm/Group Title | Arm 1 | |
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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. |
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Overall Number of Baseline Participants | 240 | |
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Study was terminated before participants could be entered into Part B.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 240 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
187 77.9%
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>=65 years |
53 22.1%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 240 participants | |
Female |
115 47.9%
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Male |
125 52.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 240 participants |
240 |
Name/Title: | Dr. Daniel Laheru |
Organization: | SKCCC |
Phone: | 410-955-8974 |
EMail: | laherda@jhmi.edu |
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 |