Trial · NCT00073983
Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma
NCT00073983, Phase 2, Completed, Sarcoma Alliance for Research through Collaboration; results first posted 2012-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma. Trials, record NCT00073983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00073983
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma
- NCT number
- NCT00073983
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Conditions
- Sarcoma
- Interventions
- filgrastim, pegfilgrastim, docetaxel, gemcitabine hydrochloride, microarray analysis, laboratory biomarker analysis, pharmacokinetic study
- First posted
- 2003-12-11
- Last updated
- 2012-03-12
- Results first posted
- 2012-03-12
- Limitations and caveats
- Since this design did not specify a rule for declaring the treatment as active a direct comparison to a standard 2 stage phase 2 design is not appropriate.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days | Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14. |
| Secondary | Time to Progression | post-cycle 2, 4, 8 and 12 | Stable disease is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started. The clinical relevance of the duration of stable disease varies for different tumor types and grades. Bayesian statistical model is used. Timepoints for evaluation are post-cycle 2, 4, 8 and 12 using RECIST 1.0 criteria. |
| Secondary | Toxicity as Assessed by NCI CTCAE v3.0 | Throughout the study | Toxicity was graded according to Common Terminology Criteria for Adverse Events v.3.0 (CTCAE v.3.0). For gemcitabine or docetaxel related grade 3 or 4 non-hematological toxicities or hematological toxicities (grade 3 or 4 neutropenia for ≥ 7 days, grade 4 thrombocytopenia, or any platelet transfusion), both agents were withheld until the toxicity was ≤ grade 1. If the toxicity recovered to ≤ grade 1 by cycle day 35, the dose of both agents was reduced for all subsequent cycles. If the toxicity did not resolve by day 35, protocol therapy was discontinued. |
| Secondary | Pharmacokinetics of Gemcitabine Alone and Gemcitabine Followed by Docetaxel at Protocol Specified Timeframe in Participants Enrolled on Study | Gemcitibine: 0hr, 75, 85, 95, 105 and 120 min after the start of the 90 minute infusion; docetaxel: 0hr, 55 min, 30 min post infusion, 5hr and 24hr post infusion. | Blood samples for the determination of gemcitabine (and its metabolite dFdU) will be obtained prior to infusion, at 75 and 85 minutes (steady state), and 95 105 and 120 minutes, after the start of the 90 minute infusion on day 1 and day 8 of cycle 1. On day 8, docetaxel pharmacokinetics will be performed prior to infusion, 55 minutes (5 minutes prior to the end of infusion), 30 minutes post infusion, 5 hr and 24hr post infusion. |
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 | Objective Response Rate | After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days | Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment. | participants | NUMBER |
| SECONDARY | Time to Progression | post-cycle 2, 4, 8 and 12 | Analysis not completed. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment. | months | NUMBER |
| SECONDARY | Toxicity as Assessed by NCI CTCAE v3.0 | Throughout the study | Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment. | participants | NUMBER |
| SECONDARY | Pharmacokinetics of Gemcitabine Alone and Gemcitabine Followed by Docetaxel at Protocol Specified Timeframe in Participants Enrolled on Study | Gemcitibine: 0hr, 75, 85, 95, 105 and 120 min after the start of the 90 minute infusion; docetaxel: 0hr, 55 min, 30 min post infusion, 5hr and 24hr post infusion. | There were insufficent samples obtained to analyze pharmacokinetics. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | Ewing's Sarcoma | 6 | participants | ||
| Objective Response Rate | Osteosarcoma | 5 | participants | ||
| Objective Response Rate | Chondrosarcoma | 14 | participants | ||
| Toxicity as Assessed by NCI CTCAE v3.0 | Ewing's Sarcoma | Toxicity | 4 | participants | |
| Toxicity as Assessed by NCI CTCAE v3.0 | Osteosarcoma | Toxicity | 3 | participants | |
| Toxicity as Assessed by NCI CTCAE v3.0 | Chondrosarcoma | Toxicity | 5 | participants | |
| Toxicity as Assessed by NCI CTCAE v3.0 | Ewing's Sarcoma | No Toxicity | 10 | participants | |
| Toxicity as Assessed by NCI CTCAE v3.0 | Osteosarcoma | No Toxicity | 11 | participants | |
| Toxicity as Assessed by NCI CTCAE v3.0 | Chondrosarcoma | No Toxicity | 20 | participants |
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 | Combination Chemotherapy | 54 | |
| Overall Study | COMPLETED | Combination Chemotherapy | 53 | |
| Overall Study | NOT COMPLETED | Combination Chemotherapy | 1 |
Source ClinicalTrials.gov
Adverse events18
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 | Grade 4 hematologic | Blood and lymphatic system disorders | Combination Chemotherapy | 14 | 53 | 24 |
| other | Grade 3 hematologic | Blood and lymphatic system disorders | Combination Chemotherapy | 22 | 53 | 58 |
| serious | cellulitis | Skin and subcutaneous tissue disorders | Combination Chemotherapy | 2 | 53 | 3 |
| serious | fever | Infections and infestations | Combination Chemotherapy | 3 | 53 | 3 |
| serious | shortness of breath | Respiratory, thoracic and mediastinal disorders | Combination Chemotherapy | 3 | 53 | 3 |
| serious | elevated WBC | Blood and lymphatic system disorders | Combination Chemotherapy | 1 | 53 | 1 |
| serious | pneumonia | Infections and infestations | Combination Chemotherapy | 3 | 53 | 3 |
| serious | hypoxia | Respiratory, thoracic and mediastinal disorders | Combination Chemotherapy | 1 | 53 | 1 |
| serious | pneumonitis | Respiratory, thoracic and mediastinal disorders | Combination Chemotherapy | 2 | 53 | 2 |
| serious | back pain | Musculoskeletal and connective tissue disorders | Combination Chemotherapy | 1 | 53 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Chemotherapy | ||
| Total, other adverse events | Combination Chemotherapy | 36 | 53 |
| Total, serious adverse events | Combination Chemotherapy | 12 | 53 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22363068 | DERIVED |
Source PubMed
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/NCT00073983
GET https://conductscience.org/api/trials/v1/NCT00073983/registered