Trial · NCT00069160
Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer
NCT00069160, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2012-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer. Trials, record NCT00069160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00069160
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer
- NCT number
- NCT00069160
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lung Neoplasms, Ovarian Neoplasms, Cervix Neoplasms, Renal Neoplasms
- Interventions
- docetaxel, tariquidar, 99mTc-sestamibi imaging
- First posted
- 2003-09-16
- Last updated
- 2012-10-12
- Results first posted
- 2012-10-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean of Maximum Concentration of the Drug (Cmax) | 24 hours | In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared. |
| Primary | The Number of Participants With Adverse Events. | 4 yrs 8-11 months | Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
| Primary | Geometric Mean of Area Under Curve (AUC0)-24 | 24 hours | |
| Primary | Clinical Response Rate | 4 years, 8-11 months | Response is determined by RECIST criteria defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesion. Lesions are either measurable or non-measurable. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/- 20 mm with conventional techniques (CT, MRI, xray) or as \>/- 10 mm with a spiral CT scan. Non-measurable lesions are defined as all other lesions (or sites of disease) including small lesions (longest diameter \<20 mm with conventional techniques or \<10 mm using spiral CT. |
| Secondary | Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar | 3 - 24 hours | A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P\<0.001. A secondary objective of this study was to establish whether tariquidar (150 mg) modulates Pgp in liver. Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. A baseline Tc-sestamibi scan was obtained before the administration of tariquidar. A minimum of 48 hours later, on or about day 22 a single dose of tariquidar was administered, followed by a second Tc-sestamibi scan. |
| Secondary | Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue | 3-24 hours | 99mTc-sestamibi is a radionuclide imaging agent used to study cardiac function that has also been shown to be a substrate for P-glycoprotein- mediated drug efflux. Because of the high expression of Pgp in liver tissue, sestamibi uptake in liver tissue is often monitored as a marker of Pgp inhibition. A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P\<0.001. |
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 | Geometric Mean of Maximum Concentration of the Drug (Cmax) | 24 hours | Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Data were evaluable in 39 patients. Paired data from 31 participants were evaluable. | Cmax (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | The Number of Participants With Adverse Events. | 4 yrs 8-11 months | participants | NUMBER | |
| PRIMARY | Geometric Mean of Area Under Curve (AUC0)-24 | 24 hours | Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Pharmacokinetic data were evaluable in 39 patients. Paired data from 31 participants were evaluable. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Clinical Response Rate | 4 years, 8-11 months | Percentage of participants | NUMBER | |
| SECONDARY | Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar | 3 - 24 hours | Percent increase in sestamibi AUC in liver after tariquidar. | percent increase in sestamibi AUC | MEDIAN |
| SECONDARY | Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue | 3-24 hours | Percent | MEDIAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean of Maximum Concentration of the Drug (Cmax) | Docetaxel Alone | C1D1 | 1315 | 95% Confidence Interval 1081 to 1598 | Cmax (ng/mL) |
| Geometric Mean of Maximum Concentration of the Drug (Cmax) | With Tariquidar | C1D1 | 1093 | 95% Confidence Interval 791.2 to 1510 | Cmax (ng/mL) |
| Geometric Mean of Maximum Concentration of the Drug (Cmax) | Docetaxel Alone | C1D8 | 1060 | 95% Confidence Interval 773.5 to 1452 | Cmax (ng/mL) |
| Geometric Mean of Maximum Concentration of the Drug (Cmax) | With Tariquidar | C1D8 | 1026 | 95% Confidence Interval 807.3 to 1303 | Cmax (ng/mL) |
| Geometric Mean of Maximum Concentration of the Drug (Cmax) | Docetaxel Alone | Both Groups (C1D1 + C1D8) | 1190 | 95% Confidence Interval 999.9 to 1416 | Cmax (ng/mL) |
| Geometric Mean of Maximum Concentration of the Drug (Cmax) | With Tariquidar | Both Groups (C1D1 + C1D8) | 1063 | 95% Confidence Interval 869.2 to 1301 | Cmax (ng/mL) |
| The Number of Participants With Adverse Events. | Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | 23 | participants | ||
| The Number of Participants With Adverse Events. | Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | 25 | participants | ||
| Geometric Mean of Area Under Curve (AUC0)-24 | Docetaxel Alone | C1D1 | 1367 | 95% Confidence Interval 1126 to 1658 | h*ng/mL |
| Geometric Mean of Area Under Curve (AUC0)-24 | With Tariquidar | C1D1 | 1409 | 95% Confidence Interval 1172 to 1694 | h*ng/mL |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22 | 23 | |
| Overall Study | STARTED | Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22 | 25 | |
| Overall Study | COMPLETED | Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22 | 23 | |
| Overall Study | COMPLETED | Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22 | 25 | |
| Overall Study | NOT COMPLETED | Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22 | 0 | |
| Overall Study | NOT COMPLETED | Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22 | 0 |
Source ClinicalTrials.gov
Adverse events288
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 | AUDITORY/HEARING:: Middle ear/hearing | Ear and labyrinth disorders | Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | 1 | 23 | 1 |
| other | AUDITORY/HEARING:: Middle ear/hearing | Ear and labyrinth disorders | Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | 0 | 25 | 0 |
| other | BLOOD/BONE MARROW:: Hemoglobin | Blood and lymphatic system disorders | Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | 18 | 23 | 130 |
| other | BLOOD/BONE MARROW:: Hemoglobin | Blood and lymphatic system disorders | Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | 21 | 25 | 72 |
| other | BLOOD/BONE MARROW:: Leukocytes (total WBC) | Blood and lymphatic system disorders | Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | 18 | 23 | 86 |
| other | BLOOD/BONE MARROW:: Leukocytes (total WBC) | Blood and lymphatic system disorders | Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | 21 | 25 | 77 |
| other | BLOOD/BONE MARROW:: Lymphopenia | Blood and lymphatic system disorders | Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | 2 | 23 | 9 |
| other | BLOOD/BONE MARROW:: Lymphopenia | Blood and lymphatic system disorders | Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | 4 | 25 | 21 |
| other | BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | 19 | 23 | 62 |
| other | BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | 16 | 25 | 41 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | ||
| Total, all-cause mortality | Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | ||
| Total, other adverse events | Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | 23 | 23 |
| Total, other adverse events | Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | 25 | 25 |
| Total, serious adverse events | Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | 6 | 23 |
| Total, serious adverse events | Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | 8 | 25 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 vs Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22: The Number of Participants With Adverse Events. | Trial comparisons |
| Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 vs Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22: serious adverse events | Trial comparisons |
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/NCT00069160
GET https://conductscience.org/api/trials/v1/NCT00069160/events?page=2