Trial · NCT00070239
Alvocidib in Treating Patients With Metastatic or Unresectable Refractory Solid Tumors or Hematologic Malignancies
NCT00070239, Phase 1, Terminated, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alvocidib in Treating Patients With Metastatic or Unresectable Refractory Solid Tumors or Hematologic Malignancies. Trials, record NCT00070239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00070239
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alvocidib in Treating Patients With Metastatic or Unresectable Refractory Solid Tumors or Hematologic Malignancies
- NCT number
- NCT00070239
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 100 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hematopoietic/Lymphoid Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- alvocidib, pharmacological study, fludeoxyglucose F 18, fluorine F 18 fluorothymidine, positron emission tomography
- First posted
- 2003-10-07
- Last updated
- 2013-12-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting toxicity (DLT) | 28 days | |
| Primary | MTD (or recommended phase II dose), defined as one dose level below that which produces two instances of DLT during the first 28-day course and the level at which no more than one of six patients experiences DLT during course 1 | 28 days | |
| Secondary | Pharmacokinetic parameters, including maximum concentration (Cmax), half-life, area under the curve (AUC), clearance, and volume of distribution | 24 hours, 48 hours, 72 hours, and 8 weeks | Determined by nonlinear regression analysis of geometric mean plasma profile. Cmax in patients w/stable disease or response at 8 weeks compared to those who progressed using Mann-Whitney test. Wilcoxon signed-rank test to compare concentration and metabolic ratios directly following infusion and 24, 48, 72 hrs later. Concentration and metabolic ratios compared in patients w/ and w/o toxicities of diarrhea, neutropenia, and asthenia using Mann- Whitney test. Fisher's exact test to assess association of flavopiridol systemic metabolism (low vs. high metabolic ratio) w/development of toxicity. |
| Secondary | Potency of alvocidib in plasma based on change in proliferation of stimulated peripheral blood mononuclear cells (PBMCs) | Baseline to up to 72 hours of day 1 course 1 | |
| Secondary | Change in tumor metabolism and proliferation assessed by fludeoxyglucose F 18 (FDG) and fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) | Baseline to up to day 19 of course 2 | Each type of pre- and post-treatment scans may be analyzed as paired data. The FDG and FLT data will be correlated to explore the relationship between tumor metabolism and tumor proliferation, for example, using Pearson or Spearman correlation coefficient. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 |
|---|---|---|---|---|---|
| U01CA062490 | Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis | KUFE, DONALD W. | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 1994 to 2013 |
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/NCT00070239
GET https://conductscience.org/api/trials/v1/NCT00070239/registered