Trial · NCT00577889
Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer
NCT00577889, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer. Trials, record NCT00577889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00577889
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer
- NCT number
- NCT00577889
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer
- Interventions
- gemcitabine hydrochloride, tanespimycin
- First posted
- 2007-12-20
- Last updated
- 2014-07-25
- Results first posted
- 2013-11-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Six Month Survival Rate | 6 months | A patient that is alive at 6 months is considered a treatment "success". Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. |
| Secondary | Overall Survival Time | Assessed up to 2 years from registration | Overall Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier. |
| Secondary | Time to Disease Progression | Time from registration to documentation of disease progression, assessed up to 2 years | The time to disease progression is defined as the time from registration to the time of confirmed disease progression using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA). Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD. |
| Secondary | Confirmed Response Rate | 2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment | A confirmed response is defined as a complete response (CR) or partial response (PR) observed in two consecutive evaluations at least 4 weeks apart using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA). Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD.Evaluated using RECIST criteria. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Six Month Survival Rate | 6 months | percentage of patients | NUMBER | |
| SECONDARY | Overall Survival Time | Assessed up to 2 years from registration | months | MEDIAN | |
| SECONDARY | Time to Disease Progression | Time from registration to documentation of disease progression, assessed up to 2 years | months | MEDIAN | |
| SECONDARY | Confirmed Response Rate | 2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Six Month Survival Rate | Arm I (Combination Chemotherapy) | 25 | 95% Confidence Interval 7.5 to 83 | percentage of patients | |
| Six Month Survival Rate | Arm II (Combination Chemotherapy) | 67 | 95% Confidence Interval 38 to 100 | percentage of patients | |
| Six Month Survival Rate | Arm III (Combination Chemotherapy) | 33 | 95% Confidence Interval 11 to 100 | percentage of patients | |
| Overall Survival Time | Arm I (Combination Chemotherapy) | 4.8 | 95% Confidence Interval 2.8 to 6.6 | months | |
| Overall Survival Time | Arm II (Combination Chemotherapy) | 6.9 | 95% Confidence Interval 2.4 to 10.7 | months | |
| Overall Survival Time | Arm III (Combination Chemotherapy) | 4.3 | 95% Confidence Interval 1.9 to 15.3 | months | |
| Time to Disease Progression | Arm I (Combination Chemotherapy) | 2.2 | 95% Confidence Interval 1.4 to 4 | months | |
| Time to Disease Progression | Arm II (Combination Chemotherapy) | 4.1 | 95% Confidence Interval 1.4 to 7.9 | months | |
| Time to Disease Progression | Arm III (Combination Chemotherapy) | 2.3 | 95% Confidence Interval 1.4 to 4.0 | months | |
| Confirmed Response Rate | Arm I (Combination Chemotherapy) | 0 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Combination Chemotherapy) | 9 | |
| Overall Study | STARTED | Arm II (Combination Chemotherapy) | 6 | |
| Overall Study | STARTED | Arm III (Combination Chemotherapy) | 6 | |
| Overall Study | COMPLETED | Arm I (Combination Chemotherapy) | 8 | |
| Overall Study | COMPLETED | Arm II (Combination Chemotherapy) | 6 | |
| Overall Study | COMPLETED | Arm III (Combination Chemotherapy) | 6 | |
| Overall Study | NOT COMPLETED | Arm I (Combination Chemotherapy) | 1 | |
| Overall Study | NOT COMPLETED | Arm II (Combination Chemotherapy) | 0 | |
| Overall Study | NOT COMPLETED | Arm III (Combination Chemotherapy) | 0 |
Source ClinicalTrials.gov
Adverse events216
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 |
|---|---|---|---|---|---|---|
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm I (Combination Chemotherapy) | 7 | 8 | 22 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm II (Combination Chemotherapy) | 4 | 6 | 15 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm III (Combination Chemotherapy) | 6 | 6 | 16 |
| other | Abdominal pain | Gastrointestinal disorders | Arm I (Combination Chemotherapy) | 6 | 8 | 13 |
| other | Abdominal pain | Gastrointestinal disorders | Arm II (Combination Chemotherapy) | 5 | 6 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Arm III (Combination Chemotherapy) | 5 | 6 | 10 |
| other | Constipation | Gastrointestinal disorders | Arm I (Combination Chemotherapy) | 0 | 8 | 0 |
| other | Constipation | Gastrointestinal disorders | Arm II (Combination Chemotherapy) | 1 | 6 | 1 |
| other | Constipation | Gastrointestinal disorders | Arm III (Combination Chemotherapy) | 1 | 6 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Arm I (Combination Chemotherapy) | 3 | 8 | 6 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Combination Chemotherapy) | ||
| Total, all-cause mortality | Arm II (Combination Chemotherapy) | ||
| Total, all-cause mortality | Arm III (Combination Chemotherapy) | ||
| Total, other adverse events | Arm I (Combination Chemotherapy) | 8 | 8 |
| Total, other adverse events | Arm II (Combination Chemotherapy) | 6 | 6 |
| Total, other adverse events | Arm III (Combination Chemotherapy) | 6 | 6 |
| Total, serious adverse events | Arm I (Combination Chemotherapy) | 6 | 8 |
| Total, serious adverse events | Arm II (Combination Chemotherapy) | 2 | 6 |
| Total, serious adverse events | Arm III (Combination Chemotherapy) | 2 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT00577889
GET https://conductscience.org/api/trials/v1/NCT00577889/events?page=2