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NCT00069160 · ClinicalTrials.gov registry record · Phase 2

Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
48
Enrollment target

NCT00069160: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00069160 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00069160, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target

Study Summary

The purpose of this study is three-fold: 1) to examine the ability of the experimental drug tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the cancer drug docetaxel; and 3) evaluate the effectiveness of combination treatment with tariquidar and docetaxel in treating patients with lung, ovarian, or cervical cancer. Patients 18 years of age and older with recurrent or metastatic (spreading) lung, cervical, or ovarian cancer who cannot benefit from any standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination; review of pathology slides; blood and urine tests; imaging tests, including computed tomography (CT) or magnetic resonance imaging (MRI) scans; chest x-ray, electrocardiogram (EKG); and possibly echocardiogram. Participants will undergo the following tests and procedures: Blood draw. Blood is drawn before treatment begins to establish baseline levels for future blood tests. Blood counts are done twice weekly after chemotherapy begins. Central venous catheter placement. A plastic tube is put into a major vein in the chest. It is used to give the study drugs or other medications, including antibiotics and blood transfusions, if needed, and to withdraw blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room. It can stay in the body for months or be removed after each treatment is completed. Chemotherapy. Treatment cycles are 21 days. Both drugs are given on day 1 of each cycle. First, tariquidar is given as a 30-minute infusion. One hour after the tariquidar infusion, docetaxel is infused over 1 hour. (For the first cycle only, docetaxel is given in divided doses one week apart and tariquidar is administered on either day 1 or day 8. The order of tariquidar administration is randomized to generate optimal

Primary Outcome

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.

Interventions

  • DRUG docetaxel
  • DRUG tariquidar
  • OTHER 99mTc-sestamibi imaging

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2003-09
Est. Completion 2009-12
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00069160 record still lists

NCT00069160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).

The record links to 0 conditions, and to 3 interventions - of which docetaxel is the first listed.

NCT00069160 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00069160 about?

NCT00069160 is a clinical study titled "Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer". The purpose of this study is three-fold: 1) to examine the ability of the experimental drug tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the cancer drug docetaxel; a...

What is the current status of trial NCT00069160?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2003-09. Estimated completion is 2009-12.

What interventions are being tested in trial NCT00069160?

The interventions under investigation include: docetaxel (DRUG), tariquidar (DRUG), 99mTc-sestamibi imaging (OTHER).

Who is sponsoring clinical trial NCT00069160?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00069160's enrollment target sits among peer trials

48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00069160, the US trial registry maintained by the National Library of Medicine. NCT00069160 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.