Trial Outcomes & Findings for Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer (NCT NCT00429858)
NCT ID: NCT00429858
Last Updated: 2020-09-18
Results Overview
Pearson's correlation coefficients ("r") will be calculated to summarize the relationship between RRM1 and response to gemcitabine. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of RRM1 and response to gemcitabine, a value of 0 indicating no association between RRM1 and response to gemcitabine, and a value of +1 indicating a positive linear association of RRM1 and response to gemcitabine.
TERMINATED
PHASE2
21 participants
Up to 2 years
2020-09-18
Participant Flow
Participant milestones
| Measure |
Targeted Therapy Group
Gemcitabine monotherapy until disease progression, followed by gemcitabine + S-1
S-1: S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)
Gemcitabine hydrochloride: Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Targeted Therapy Group
Gemcitabine monotherapy until disease progression, followed by gemcitabine + S-1
S-1: S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)
Gemcitabine hydrochloride: Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Study Termination
|
1
|
Baseline Characteristics
Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Targeted Therapy Group
n=21 Participants
Gemcitabine monotherapy until disease progression, followed by gemcitabine + S-1.
S-1: S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)
Gemcitabine hydrochloride: Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle
|
|---|---|
|
Age, Customized
40-49 years old
|
2 Participants
n=93 Participants
|
|
Age, Customized
50-59 years old
|
5 Participants
n=93 Participants
|
|
Age, Customized
60-69 years old
|
11 Participants
n=93 Participants
|
|
Age, Customized
70-79 years old
|
2 Participants
n=93 Participants
|
|
Age, Customized
80-89 years old
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Historical records were discarded in accordance with university record retention policy.
Pearson's correlation coefficients ("r") will be calculated to summarize the relationship between RRM1 and response to gemcitabine. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of RRM1 and response to gemcitabine, a value of 0 indicating no association between RRM1 and response to gemcitabine, and a value of +1 indicating a positive linear association of RRM1 and response to gemcitabine.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Historical records were discarded in accordance with university record retention policy.
Pearson's correlation coefficients ("r") will be calculated to summarize the relationship between deoxycytidine kinase (dCK), equilibrative nucleoside transporter 1 (ENT1) and concentrative nucleoside transporters 1 and 3 (CNT1 and CNT3), with response to gemcitabine in a table format. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of intratumoral expression levels and response to gemcitabine, a value of 0 indicating no association between intratumoral expression levels and response to gemcitabine, and a value of +1 indicating a positive linear association of intratumoral expression levels and response to gemcitabine.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Historical records were discarded in accordance with university record retention policy.
Pearson's correlation coefficients ("r") will be calculated to summarize the relationship between intratumoral expression levels of thymidylate synthase (TS), thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), orotate phosphoribosyltransferase (ORPT) with response to the combination of gemcitabine/S-1 in a table format. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of intratumoral expression levels and the combination of gemcitabine/S-1, a value of 0 indicating no association between intratumoral expression levels and response to the combination of gemcitabine/S-1, and a value of +1 indicating a positive linear association of intratumoral expression levels and response to the combination of gemcitabine/S-1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Historical records were discarded in accordance with university record retention policy.
Overall survival will be defined from the date of receiving the first treatment until death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeks after 6th patient is enrolledPopulation: Historical records were discarded in accordance with university record retention policy.
Treatment-related toxicities resulting in a dose modification be classified using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 will be tabulated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed after the first 5 weeks of treatmentPopulation: Historical records were discarded in accordance with university record retention policy.
Defined as the percentage of patients who will be categorized as potential biomarker responders if their CA19-9 has declined by \> 10 % from peak value (peak value may have been at either week 1 or 3) during the initial gemcitabine monotherapy phase
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Historical records were discarded in accordance with university record retention policy.
Time to progression will be summarized according to the method of Kaplan and Meier
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Historical records were discarded in accordance with university record retention policy.
A biomarker response for any given line of therapy is defined as patients with a baseline CA19-9 level \> 75 units per cubic centimeter (U/cc) who demonstrate a \> 25% decline in their peak CA19-9 level, sustainable for at least 2 consecutive measurements
Outcome measures
Outcome data not reported
Adverse Events
Targeted Therapy Group
Serious adverse events
| Measure |
Targeted Therapy Group
n=21 participants at risk
Gemcitabine monotherapy until disease progression, followed by gemcitabine + S-1.
S-1: S-1 is given as follows: 25 mg/m2 bid on days 1-7 and 15-21 of the cycle (28 days)
Gemcitabine hydrochloride: Patients will receive gemcitabine at a dose of 1,000 mg/m2 i.v. at a fixed-dose rate (FDR) infusion of 10 mg/m2/minute (100 minutes), once a week for 3 consecutive weeks, followed by one week rest. Each 4 week period is referred to as a treatment cycle
|
|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
4.8%
1/21 • Number of events 1 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
Gastrointestinal disorders
Colitis
|
4.8%
1/21 • Number of events 1 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
Blood and lymphatic system disorders
Thrombosis/thrombus/embolism
|
9.5%
2/21 • Number of events 2 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.5%
2/21 • Number of events 4 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Number of events 2 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
Gastrointestinal disorders
Vomitting
|
4.8%
1/21 • Number of events 1 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
4.8%
1/21 • Number of events 1 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
General disorders
Pain, NOS
|
9.5%
2/21 • Number of events 2 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
Nervous system disorders
Encephalopathy
|
4.8%
1/21 • Number of events 1 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Duodenum
|
4.8%
1/21 • Number of events 1 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
Respiratory, thoracic and mediastinal disorders
Hypertension
|
4.8%
1/21 • Number of events 2 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
|
Vascular disorders
Pulmonary embolism
|
4.8%
1/21 • Number of events 1 • Up to 2 years
Data for non-serious adverse events was not migrated from legacy clinical trials management system, due to the study closure with the University of California, San Francisco (UCSF) institutional review board (IRB) prior to system migration. Historical records were discarded in accordance with university record retention policy.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrew Ko, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place