Trial · NCT00098579
Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery
NCT00098579, Phase 1, Completed, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery. Trials, record NCT00098579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00098579
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery
- NCT number
- NCT00098579
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Gastrointestinal Stromal Tumor, Recurrent Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
- Interventions
- alvocidib, doxorubicin hydrochloride
- First posted
- 2004-12-08
- Last updated
- 2013-03-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD of alvocidib when given every three weeks in conjunction with doxorubicin hydrochloride | Course 1 | Defined as the dose level immediately preceding the dose where 2 or more patients experienced DLT. |
| Secondary | Dose limiting toxicity | Weekly during course 1 at initiation of each course thereafter | Defined as the occurrence of Grade 4 hematologic toxicity 21 days after treatment, Grade 4 hematologic toxicity lasting 7 days or longer, Grade 3 or 4 non-hematologic toxicity, or any delay in treatment of more than two weeks. Evaluated using the National Cancer Institute (NCI) Common Toxicity Criteria. Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. |
| Secondary | Clinical pharmacokinetics of the regimen | Week 1 | Biopsies will be performed by Tru-Cut or CT guidance. The material obtained will be examined for p21, p53 and pRb expression by immunohistochemistry (IHC) as well as measurements of apoptosis by terminal deoxynucleotidyl transferase (TdT)- mediated dUTP nick end labeling (TUNEL). |
| Secondary | Therapeutic activity of alvocidib in combination with doxorubicin hydrochloride in patients with advanced solid tumors | Every 2 courses for the first 6 courses and every 3 courses thereafter | Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. |
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 |
|---|---|---|---|---|---|
| U01CA069856 | Early Clinical Trials of New Anti-Cancer Agents with Phase 1 Emphasis | SPRIGGS, DAVID R | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1995 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/NCT00098579
GET https://conductscience.org/api/trials/v1/NCT00098579/registered