Trial · NCT00869050
Capecitabine and Temozolomide for Neuroendocrine Cancers
NCT00869050, Phase 2, Completed, Columbia University; results first posted 2016-06-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Capecitabine and Temozolomide for Neuroendocrine Cancers. Trials, record NCT00869050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00869050
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Capecitabine and Temozolomide for Neuroendocrine Cancers
- NCT number
- NCT00869050
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Neuroendocrine Tumors
- Interventions
- Capecitabine, Temozolomide
- First posted
- 2009-03-25
- Last updated
- 2016-07-25
- Results first posted
- 2016-06-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Partial Response (PR) | 12 months | PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting \> 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements. |
| Primary | Number of Participants With Complete Response (CR) | 12 months | CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for \>4 weeks, during which no new lesions may appear and no existing lesion may enlarge. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Partial Response (PR) | 12 months | 28/38 analyzed. | participants | NUMBER |
| PRIMARY | Number of Participants With Complete Response (CR) | 12 months | 28/38 analyzed. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Partial Response (PR) | Capecitabine and Temozolomide | 9 | participants | ||
| Number of Participants With Complete Response (CR) | Capecitabine and Temozolomide | 3 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Capecitabine and Temozolomide | 41 | |
| Overall Study | COMPLETED | Capecitabine and Temozolomide | 38 | |
| Overall Study | NOT COMPLETED | Capecitabine and Temozolomide | 3 |
Source ClinicalTrials.gov
Adverse events31
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 | Pain abdomen | Gastrointestinal disorders | Capecitabine and Temozolomide | 2 | 38 | 2 |
| other | Erythema | Skin and subcutaneous tissue disorders | Capecitabine and Temozolomide | 1 | 38 | 1 |
| other | Facial flushing | Skin and subcutaneous tissue disorders | Capecitabine and Temozolomide | 2 | 38 | 2 |
| other | Fatigue | General disorders | Capecitabine and Temozolomide | 5 | 38 | 5 |
| other | Dizziness | General disorders | Capecitabine and Temozolomide | 1 | 38 | 1 |
| other | Night sweats | General disorders | Capecitabine and Temozolomide | 2 | 38 | 2 |
| other | Vomiting | General disorders | Capecitabine and Temozolomide | 1 | 38 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Capecitabine and Temozolomide | 5 | 38 | 5 |
| other | Confusion | General disorders | Capecitabine and Temozolomide | 1 | 38 | 1 |
| other | Loss of apetite | General disorders | Capecitabine and Temozolomide | 2 | 38 | 2 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Capecitabine and Temozolomide | ||
| Total, other adverse events | Capecitabine and Temozolomide | 28 | 38 |
| Total, serious adverse events | Capecitabine and Temozolomide | 4 | 38 |
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/NCT00869050
GET https://conductscience.org/api/trials/v1/NCT00869050/events?page=2