Trial · NCT00429858
Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer
NCT00429858, Phase 2, Terminated, Andrew Ko; results first posted 2020-09-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer. Trials, record NCT00429858. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00429858
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer
- NCT number
- NCT00429858
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Andrew Ko
- Conditions
- Pancreatic Cancer
- Interventions
- S-1, gemcitabine hydrochloride
- First posted
- 2007-02-01
- Last updated
- 2020-09-18
- Results first posted
- 2020-09-18
- Limitations and caveats
- Historical records were discarded in accordance with university record retention policy. Data electronically archived to the current clinical trial management system has been reported where possible.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Correlate Intratumoral Expression Level of Ribonucleotide Reductase Subunit 1 (RRM1) With Response to Gemcitabine in Patients With Advanced Pancreatic Cancer. | Up to 2 years | 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. |
| Secondary | Correlate Intratumoral Expression Levels of Other Genes, Including Deoxycytidine Kinase (dCK), Equilibrative Nucleoside Transporter 1 (ENT1) and Concentrative Nucleoside Transporters 1 and 3 (CNT1 and CNT3), With Response to Gemcitabine. | Up to 2 years | 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. |
| Secondary | Correlate 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. | Up to 2 years | 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. |
| Secondary | Median Overall Survival | Up to 2 years | Overall survival will be defined from the date of receiving the first treatment until death |
| Secondary | Number of Patients With Dose Modifications | 8 weeks after 6th patient is enrolled | 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. |
| Secondary | Percentage of Patients Classified as Potential Biomarker Responders | Assessed after the first 5 weeks of treatment | 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 |
| Secondary | Median Time to Progression | Up to 2 years | Time to progression will be summarized according to the method of Kaplan and Meier |
| Secondary | Percentage of Patients With at Biomarker Response | Up to 2 years | 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 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Correlate Intratumoral Expression Level of Ribonucleotide Reductase Subunit 1 (RRM1) With Response to Gemcitabine in Patients With Advanced Pancreatic Cancer. | Up to 2 years | Historical records were discarded in accordance with university record retention policy. | ||
| SECONDARY | Correlate Intratumoral Expression Levels of Other Genes, Including Deoxycytidine Kinase (dCK), Equilibrative Nucleoside Transporter 1 (ENT1) and Concentrative Nucleoside Transporters 1 and 3 (CNT1 and CNT3), With Response to Gemcitabine. | Up to 2 years | Historical records were discarded in accordance with university record retention policy. | ||
| SECONDARY | Correlate 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. | Up to 2 years | Historical records were discarded in accordance with university record retention policy. | ||
| SECONDARY | Median Overall Survival | Up to 2 years | Historical records were discarded in accordance with university record retention policy. | ||
| SECONDARY | Number of Patients With Dose Modifications | 8 weeks after 6th patient is enrolled | Historical records were discarded in accordance with university record retention policy. | ||
| SECONDARY | Percentage of Patients Classified as Potential Biomarker Responders | Assessed after the first 5 weeks of treatment | Historical records were discarded in accordance with university record retention policy. | ||
| SECONDARY | Median Time to Progression | Up to 2 years | Historical records were discarded in accordance with university record retention policy. | ||
| SECONDARY | Percentage of Patients With at Biomarker Response | Up to 2 years | Historical records were discarded in accordance with university record retention policy. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Targeted Therapy Group | 21 | |
| Overall Study | COMPLETED | Targeted Therapy Group | 19 | |
| Overall Study | NOT COMPLETED | Targeted Therapy Group | 2 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Targeted Therapy Group | 1 | 21 | 1 |
| serious | Colitis | Gastrointestinal disorders | Targeted Therapy Group | 1 | 21 | 1 |
| serious | Thrombosis/thrombus/embolism | Blood and lymphatic system disorders | Targeted Therapy Group | 2 | 21 | 2 |
| serious | Abdominal Pain | Gastrointestinal disorders | Targeted Therapy Group | 2 | 21 | 4 |
| serious | Nausea | Gastrointestinal disorders | Targeted Therapy Group | 2 | 21 | 2 |
| serious | Vomitting | Gastrointestinal disorders | Targeted Therapy Group | 1 | 21 | 1 |
| serious | Hyperbilirubinemia | Hepatobiliary disorders | Targeted Therapy Group | 1 | 21 | 1 |
| serious | Pain, NOS | General disorders | Targeted Therapy Group | 2 | 21 | 2 |
| serious | Encephalopathy | Nervous system disorders | Targeted Therapy Group | 1 | 21 | 1 |
| serious | Hemorrhage, GI - Duodenum | Gastrointestinal disorders | Targeted Therapy Group | 1 | 21 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Targeted Therapy Group | 7 | 21 |
| Total, other adverse events | Targeted Therapy Group | 0 | 0 |
| Total, serious adverse events | Targeted Therapy Group | 9 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA082103 | Cancer Center Support Grant | ASHWORTH, ALAN | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL CANCER INSTITUTE | 1999 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00429858
GET https://conductscience.org/api/trials/v1/NCT00429858/registered