Trial · NCT00098956
7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer
NCT00098956, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-09-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer. Trials, record NCT00098956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00098956
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer
- NCT number
- NCT00098956
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
- Interventions
- topotecan hydrochloride, 7-hydroxystaurosporine
- First posted
- 2004-12-09
- Last updated
- 2018-07-23
- Results first posted
- 2015-09-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria | Up to 5 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. |
| Secondary | Stable Disease Rate Evaluated Using RECIST Criteria | Up to 5 years | Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. |
| Secondary | Duration of Responses | From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years | |
| Secondary | Progression-free Survival | From the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years | |
| Secondary | Overall Survival | From the date of enrollment to death or last contact, assessed up to 5 years | |
| Secondary | Adverse Events, Graded Using the CTCAE Version 3.0 | Up to 5 years |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria | Up to 5 years | participants | NUMBER | |
| SECONDARY | Stable Disease Rate Evaluated Using RECIST Criteria | Up to 5 years | participants | NUMBER | |
| SECONDARY | Duration of Responses | From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years | Data were not collected | ||
| SECONDARY | Progression-free Survival | From the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years | Data were not collected | ||
| SECONDARY | Overall Survival | From the date of enrollment to death or last contact, assessed up to 5 years | Data were not collected | ||
| SECONDARY | Adverse Events, Graded Using the CTCAE Version 3.0 | Up to 5 years | types of grade 3 / 4 toxicities reported | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria | Treatment (Topotecan Hydrochloride, UCN-01) | 2 | participants | ||
| Stable Disease Rate Evaluated Using RECIST Criteria | Treatment (Topotecan Hydrochloride, UCN-01) | 9 | participants | ||
| Adverse Events, Graded Using the CTCAE Version 3.0 | Treatment (Topotecan Hydrochloride, UCN-01) | 7 | types of grade 3 / 4 toxicities reported |
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 | Treatment (Topotecan Hydrochloride, UCN-01) | 19 | |
| Overall Study | COMPLETED | Treatment (Topotecan Hydrochloride, UCN-01) | 19 | |
| Overall Study | NOT COMPLETED | Treatment (Topotecan Hydrochloride, UCN-01) | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Neutrophil count decreased | Investigations | Treatment (Topotecan Hydrochloride, UCN-01) | 13 | 19 | 13 |
| other | White blood cell decreased | Investigations | Treatment (Topotecan Hydrochloride, UCN-01) | 14 | 19 | 14 |
| other | Platelet count decreased | Investigations | Treatment (Topotecan Hydrochloride, UCN-01) | 6 | 19 | 6 |
| serious | Death NOS | General disorders | Treatment (Topotecan Hydrochloride, UCN-01) | 1 | 19 | 1 |
| serious | Sinus Tachycardia | Cardiac disorders | Treatment (Topotecan Hydrochloride, UCN-01) | 1 | 19 | 1 |
| serious | Cardiac disorder other | Cardiac disorders | Treatment (Topotecan Hydrochloride, UCN-01) | 1 | 19 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Topotecan Hydrochloride, UCN-01) | ||
| Total, other adverse events | Treatment (Topotecan Hydrochloride, UCN-01) | 19 | 19 |
| Total, serious adverse events | Treatment (Topotecan Hydrochloride, UCN-01) | 3 | 19 |
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/NCT00098956
GET https://conductscience.org/api/trials/v1/NCT00098956/registered