Trial · NCT00991952
Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery
NCT00991952, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-01-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery. Trials, record NCT00991952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00991952
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery
- NCT number
- NCT00991952
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Recurrent Gastric Cancer, Stage IIIA Gastric Cancer, Stage IIIB Gastric Cancer, Stage IIIC Gastric Cancer, Stage IV Gastric Cancer
- Interventions
- alvocidib, irinotecan hydrochloride, laboratory biomarker analysis
- First posted
- 2009-10-08
- Last updated
- 2014-05-26
- Results first posted
- 2014-01-21
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | From the start of treatment for up to 3 months | Response was determined as indicated in the protocol. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | From the start of treatment for up to 3 months | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Overall Response Rate | Irinotecan Hydrochloride and Alvocidib | Partial Response | 1 | participants | |
| Overall Response Rate | Irinotecan Hydrochloride | Partial Response | 0 | participants | |
| Overall Response Rate | Irinotecan Hydrochloride and Alvocidib | Stable Disease | 4 | participants | |
| Overall Response Rate | Irinotecan Hydrochloride | Stable Disease | 1 | participants | |
| Overall Response Rate | Irinotecan Hydrochloride and Alvocidib | Progression of Disease | 8 | participants | |
| Overall Response Rate | Irinotecan Hydrochloride | Progression of Disease | 4 | participants |
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 | Irinotecan Hydrochloride and Alvocidib | 13 | |
| Overall Study | STARTED | Irinotecan Hydrochloride | 6 | |
| Overall Study | COMPLETED | Irinotecan Hydrochloride and Alvocidib | 13 | |
| Overall Study | COMPLETED | Irinotecan Hydrochloride | 5 | |
| Overall Study | NOT COMPLETED | Irinotecan Hydrochloride and Alvocidib | 0 | |
| Overall Study | NOT COMPLETED | Irinotecan Hydrochloride | 1 |
Source ClinicalTrials.gov
Adverse events138
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 | Abdominal distension | Gastrointestinal disorders | Irinotecan Hydrochloride and Alvocidib | 1 | 13 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Irinotecan Hydrochloride | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Irinotecan Hydrochloride and Alvocidib | 1 | 13 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Irinotecan Hydrochloride | 0 | 6 | 0 |
| other | Alanine aminotransferase increased | Investigations | Irinotecan Hydrochloride and Alvocidib | 3 | 13 | 3 |
| other | Alanine aminotransferase increased | Investigations | Irinotecan Hydrochloride | 1 | 6 | 1 |
| other | Alkaline phosphatase increased | Investigations | Irinotecan Hydrochloride and Alvocidib | 4 | 13 | 4 |
| other | Alkaline phosphatase increased | Investigations | Irinotecan Hydrochloride | 1 | 6 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Irinotecan Hydrochloride and Alvocidib | 9 | 13 | 9 |
| other | Anemia | Blood and lymphatic system disorders | Irinotecan Hydrochloride | 2 | 6 | 2 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Irinotecan Hydrochloride and Alvocidib | ||
| Total, all-cause mortality | Irinotecan Hydrochloride | ||
| Total, other adverse events | Irinotecan Hydrochloride and Alvocidib | 13 | 13 |
| Total, other adverse events | Irinotecan Hydrochloride | 6 | 6 |
| Total, serious adverse events | Irinotecan Hydrochloride and Alvocidib | 6 | 13 |
| Total, serious adverse events | Irinotecan Hydrochloride | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Irinotecan Hydrochloride and Alvocidib vs Irinotecan Hydrochloride: 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/NCT00991952
GET https://conductscience.org/api/trials/v1/NCT00991952/events?page=2