Trial · NCT00859469
Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma
NCT00859469, Phase 2, Completed, Columbia University; results first posted 2012-02-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma. Trials, record NCT00859469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00859469
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma
- NCT number
- NCT00859469
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Mesothelioma
- Interventions
- Oxaliplatin, Gemcitabine
- First posted
- 2009-03-11
- Last updated
- 2019-10-30
- Results first posted
- 2012-02-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Response | Two months | Radiologic response by RECIST criteria will be compared between baseline and at 2 months. Disease assessment: Two objective status determinations of CR before progression are required for a best response of CR. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Two determinations of stable/no response or better before progression, but not qualifying as CR or PR are required for a best response of stable/no response. |
| Secondary | Overall Survival | 50 months | |
| Secondary | Progression-free Survival | 50 months | Time to radiologic disease progression or death |
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 | Best Response | Two months | intention to treat principle | participants | NUMBER |
| SECONDARY | Overall Survival | 50 months | ITT | months | MEDIAN |
| SECONDARY | Progression-free Survival | 50 months | 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 |
|---|---|---|---|---|---|
| Best Response | Oxaliplatin and Gemcitabine | Complete Response | 0 | participants | |
| Best Response | Oxaliplatin and Gemcitabine | Partial Response | 7 | participants | |
| Best Response | Oxaliplatin and Gemcitabine | Stable Disease | 11 | participants | |
| Best Response | Oxaliplatin and Gemcitabine | Progressive Disease | 11 | participants | |
| Overall Survival | Oxaliplatin and Gemcitabine | 8 | 95% Confidence Interval 4 to 14 | months | |
| Progression-free Survival | Oxaliplatin and Gemcitabine | 5 | 95% Confidence Interval 2 to 7 | months |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxaliplatin and Gemcitabine | 29 | |
| Overall Study | 6 Cycles | Oxaliplatin and Gemcitabine | 16 | |
| Overall Study | COMPLETED | Oxaliplatin and Gemcitabine | 1 | |
| Overall Study | NOT COMPLETED | Oxaliplatin and Gemcitabine | 28 |
Source ClinicalTrials.gov
Adverse events21
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 | Leukopenia | Blood and lymphatic system disorders | Oxaliplatin and Gemcitabine | 5 | 26 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Oxaliplatin and Gemcitabine | 16 | 28 | |
| other | Anemia | Blood and lymphatic system disorders | Oxaliplatin and Gemcitabine | 23 | 26 | |
| other | Elevated alkaline phosphatase | Hepatobiliary disorders | Oxaliplatin and Gemcitabine | 15 | 26 | |
| other | Elevated AST | Hepatobiliary disorders | Oxaliplatin and Gemcitabine | 13 | 26 | |
| other | Elevated ALT | Hepatobiliary disorders | Oxaliplatin and Gemcitabine | 14 | 26 | |
| other | Nausea/Vomiting | Gastrointestinal disorders | Oxaliplatin and Gemcitabine | 9 | 29 | |
| other | Diarrhea | Gastrointestinal disorders | Oxaliplatin and Gemcitabine | 2 | 29 | |
| other | Peripheral neuropathy | Nervous system disorders | Oxaliplatin and Gemcitabine | 11 | 29 | |
| other | Fever | General disorders | Oxaliplatin and Gemcitabine | 2 | 29 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxaliplatin and Gemcitabine | ||
| Total, other adverse events | Oxaliplatin and Gemcitabine | 27 | |
| Total, serious adverse events | Oxaliplatin and Gemcitabine | 11 | 28 |
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/NCT00859469
GET https://conductscience.org/api/trials/v1/NCT00859469/events?page=2