Trial · NCT00066781
Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
NCT00066781, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-04-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary. Trials, record NCT00066781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00066781
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
- NCT number
- NCT00066781
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Carcinoma of Unknown Primary
- Interventions
- gemcitabine hydrochloride, irinotecan hydrochloride
- First posted
- 2003-08-07
- Last updated
- 2017-04-04
- Results first posted
- 2017-04-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria | Up to 2 years | The primary endpoint is confirmed response rate. If measurable disease is present, a confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. All registered patients meeting the eligibility criteria that have signed a consent form and have begun treatment will be evaluable for response. |
| Secondary | Overall Survival | Up to 2 years | Overall survival time is defined as the time from registration to death due\> to any cause. The distribution of survival time will be estimated using\> the method of Kaplan-Meier . Overall survival will be calculated for\> all evaluable patients combined and by group (ie. for patients with or\> without the UGT1A1\*28 polymorphism). |
| Secondary | Time to Disease Progression | Up to 2 years | Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Time to disease progression will be calculated for all evaluable patients combined and by group (ie. for patients with or without the UGT1A1\*28 polymorphism). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria | Up to 2 years | All evaluable patients | percentage of patients with response | NUMBER |
| SECONDARY | Overall Survival | Up to 2 years | Months | MEDIAN | |
| SECONDARY | Time to Disease Progression | Up to 2 years | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria | Cohort I | 9 | 95% Confidence Interval 0 to 41 | percentage of patients with response | |
| Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria | Cohort II | 13 | 95% Confidence Interval 2 to 40 | percentage of patients with response | |
| Overall Survival | Cohort I | 4 | 95% Confidence Interval 2.2 to 15.6 | Months | |
| Overall Survival | Cohort II | 9.3 | 95% Confidence Interval 4.1 to 12.1 | Months | |
| Time to Disease Progression | Cohort I | 3.7 | 95% Confidence Interval 1.7 to 7.8 | Months | |
| Time to Disease Progression | Cohort II | 3.4 | 95% Confidence Interval 1.6 to 9.3 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort I | 14 | |
| Overall Study | STARTED | Cohort II | 17 | |
| Overall Study | COMPLETED | Cohort I | 14 | |
| Overall Study | COMPLETED | Cohort II | 17 | |
| Overall Study | NOT COMPLETED | Cohort I | 0 | |
| Overall Study | NOT COMPLETED | Cohort II | 0 |
Source ClinicalTrials.gov
Adverse events110
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 | Febrile neutropenia | Blood and lymphatic system disorders | Cohort I | 1 | 14 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort II | 2 | 17 | 2 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Cohort I | 4 | 14 | 5 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Cohort II | 3 | 17 | 3 |
| other | Hemolysis | Blood and lymphatic system disorders | Cohort I | 1 | 14 | 1 |
| other | Hemolysis | Blood and lymphatic system disorders | Cohort II | 0 | 17 | 0 |
| other | Myocardial ischemia | Cardiac disorders | Cohort I | 1 | 14 | 1 |
| other | Myocardial ischemia | Cardiac disorders | Cohort II | 0 | 17 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort I | 1 | 14 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort II | 5 | 17 | 5 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort I | ||
| Total, all-cause mortality | Cohort II | ||
| Total, other adverse events | Cohort I | 14 | 14 |
| Total, other adverse events | Cohort II | 16 | 17 |
| Total, serious adverse events | Cohort I | 0 | 14 |
| Total, serious adverse events | Cohort II | 0 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22815703 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cohort I vs Cohort II: serious adverse events |
Source Trial comparisons
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/NCT00066781
GET https://conductscience.org/api/trials/v1/NCT00066781/events?page=2