Trial · NCT00093496
Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer
NCT00093496, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer. Trials, record NCT00093496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00093496
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 Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer
- NCT number
- NCT00093496
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer
- Interventions
- gemcitabine hydrochloride, tanespimycin
- First posted
- 2004-10-08
- Last updated
- 2014-05-20
- Results first posted
- 2013-07-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria. | Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum). | Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline. |
| Secondary | Times to Progression | Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration. | Defined as the time from registration to the date of progression or last follow-up, whichever comes first. Estimated using the method of Kaplan-Meier |
| Secondary | Overall Survival | Every 3 months until disease progression and then every 6 months for up to 5 years. | Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier. |
| Secondary | Toxicity | Participants were evaluated every 6 weeks on treatment (maximum 42 weeks) | Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as an adverse event classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. |
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 | Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria. | Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum). | In Cohort 1, one patient was found to be ineligible. In Cohort 2, one patient was ineligible and two patients had protocol violations. Therefore, 14 participants in Cohort 1 and eleven participants in Cohort 2 were analyzed for the primary endpoint. | proportion of participants | NUMBER |
| SECONDARY | Times to Progression | Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration. | An interim analysis was done on the first 12 eligible participants in each cohort. Due to drug shortage and lack of clinical activity, the interim analysis for Cohort 2 was conducted on the first 11 participants. | months | MEDIAN |
| SECONDARY | Overall Survival | Every 3 months until disease progression and then every 6 months for up to 5 years. | An interim analysis was done on the first 12 eligible participants in each cohort. Due to drug shortage and lack of clinical acttivity, the interim analysis for Cohort 2 was conducted on the first 11 participants. | months | MEDIAN |
| SECONDARY | Toxicity | Participants were evaluated every 6 weeks on treatment (maximum 42 weeks) | In Cohort 1, one patient was found to be ineligible. In Cohort 2, one patient was ineligible and two patients had protocol violations. Therefore, 14 participants in Cohort 1 and eleven participants in Cohort 2 were analyzed for adverse events. | events | 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 |
|---|---|---|---|---|---|
| Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria. | Cohort 1 (No Prior Gemcitabine Exposure) | Confirmed Partial Response (PR) | 0.071 | proportion of participants | |
| Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria. | Cohort 2 (Prior Gemcitabine Exposure) | Confirmed Partial Response (PR) | 0 | proportion of participants | |
| Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria. | Cohort 1 (No Prior Gemcitabine Exposure) | Confirmed Complete Response (CR) | 0 | proportion of participants | |
| Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria. | Cohort 2 (Prior Gemcitabine Exposure) | Confirmed Complete Response (CR) | 0 | proportion of participants | |
| Times to Progression | Cohort 1 (No Prior Gemcitabine Exposure) | 1.6 | 95% Confidence Interval 1.2 to 3.5 | months | |
| Times to Progression | Cohort 2 (Prior Gemcitabine Exposure) | 2.7 | 95% Confidence Interval 1.3 to 5.1 | months | |
| Overall Survival | Cohort 1 (No Prior Gemcitabine Exposure) | 18.3 | 95% Confidence Interval 6.2 to NA | months | |
| Overall Survival | Cohort 2 (Prior Gemcitabine Exposure) | 11.5 | 95% Confidence Interval 4.0 to 13.7 | months | |
| Toxicity | Cohort 1 (No Prior Gemcitabine Exposure) | Grade 3 | 9 | events | |
| Toxicity | Cohort 2 (Prior Gemcitabine Exposure) | Grade 3 | 7 | events |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (No Prior Gemcitabine Exposure) | 15 | |
| Overall Study | STARTED | Cohort 2 (Prior Gemcitabine Exposure) | 14 | |
| Overall Study | COMPLETED | Cohort 1 (No Prior Gemcitabine Exposure) | 14 | |
| Overall Study | COMPLETED | Cohort 2 (Prior Gemcitabine Exposure) | 11 | |
| Overall Study | NOT COMPLETED | Cohort 1 (No Prior Gemcitabine Exposure) | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2 (Prior Gemcitabine Exposure) | 3 |
Source ClinicalTrials.gov
Adverse events41
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 | All Patients Receiving Gemcitabine | 24 | 29 | 79 |
| other | Abdominal pain | Gastrointestinal disorders | All Patients Receiving Gemcitabine | 3 | 29 | 6 |
| other | Constipation | Gastrointestinal disorders | All Patients Receiving Gemcitabine | 3 | 29 | 8 |
| other | Diarrhea | Gastrointestinal disorders | All Patients Receiving Gemcitabine | 9 | 29 | 15 |
| other | Flatulence | Gastrointestinal disorders | All Patients Receiving Gemcitabine | 1 | 29 | 1 |
| other | Gastric ulcer | Gastrointestinal disorders | All Patients Receiving Gemcitabine | 1 | 29 | 1 |
| other | Nausea | Gastrointestinal disorders | All Patients Receiving Gemcitabine | 16 | 29 | 26 |
| other | Stomach pain | Gastrointestinal disorders | All Patients Receiving Gemcitabine | 1 | 29 | 3 |
| other | Vomiting | Gastrointestinal disorders | All Patients Receiving Gemcitabine | 10 | 29 | 13 |
| other | Edema limbs | General disorders | All Patients Receiving Gemcitabine | 1 | 29 | 3 |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients Receiving Gemcitabine | ||
| Total, other adverse events | All Patients Receiving Gemcitabine | 28 | 29 |
| Total, serious adverse events | All Patients Receiving Gemcitabine | 10 | 29 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00093496
GET https://conductscience.org/api/trials/v1/NCT00093496/events?page=2