Randomized, Multi-center, Open-label, Study of PR104 Versus PR104/Docetaxel in Non-Small Cell Lung Cancer (NSCLC)
Public ClinicalTrials.gov record NCT00862134. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The current understanding of PR104 justifies the evaluation of PR104 with docetaxel in subjects with Non Small Cell Lung Cancer (NSCLC). These include: * Aldo-keto reductase 1C3 (AKR1C3). NSCLC has been shown to express high levels of AKR1C3 in about one half of tumors tested. Subjects with high levels of AKR1C3 should have increased activation of PR104 within their tumor. * Hypoxia. NSCLC has been demonstrated to be a tumor with hypoxia based on both direct tumor measurements (oxygen electrodes) and hypoxic positron emission tomography (PET) imaging. Tumor hypoxia in NSCLC should be sufficient to activate PR104 to its active metabolites PR104H and PR104M. * Preclinical data. The use of docetaxel and PR104 alone and in combination in preclinical models demonstrates activity of PR104 as a single agent and supraadditive activity when PR104 and docetaxel are used in combination. * Manageable toxicity. PR104 and docetaxel with Granulocyte Colony-stimulating Factor (G-CSF) have been combined in a prior phase I study. A Maximum Tolerated Dose (MTD) has been identified and the major toxicities of this combination are understood. The current study will provide an estimate of the activity of PR104 in subjects with NSCLC. This information will prove valuable in defining the future clinical development of PR104, and in determining if PR104 has sufficient activity in NSCLC to warrant a larger phase III registration study in this indication. Primary objectives • Estimate the response rate (RR) of PR104/docetaxel Secondary objectives * Evaluate survival * Evaluate progression free survival (PFS) * Evaluate time to progression (TTP) * Evaluate safety * Evaluate the pharmacokinetics of PR104 and its metabolites * Evaluate the pharmacokinetics of docetaxel * Evaluate the tumor hypoxia using 18F-fluoromisonidazole (18F-MISO) PET imaging * Collect diagnostic biopsy samples for the determination of AKR1C3 * Collect plasma samples for assessment of potential biomarkers of tumor hypoxia
Study identification
- NCT ID
- NCT00862134
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2009 (Type not available)
- Primary completion
- Jan 2010 (Actual)
- Completion
- May 2010 (Actual)
- Last update posted
- Jan 10, 2013
2009 – 2010
United States locations
- U.S. sites
- 25
- U.S. states
- 17
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sharp Clinical Oncology Research | San Diego | California | 92123 | — |
| University of Miami/Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Orchard Research, LLC | Skokie | Illinois | 60076 | — |
| Midwestern Regional Medical Center | Zion | Illinois | 60099 | — |
| St. Francis Health Services | Beech Grove | Indiana | 46107 | — |
| McFarland Clinic/William R. Bliss Cancer Center | Ames | Iowa | 50010 | — |
| Iowa Blood & Cancer Care | Cedar Rapids | Iowa | 52402 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | — |
| Montgomery Cancer Center | Mount Sterling | Kentucky | 40353 | — |
| Baton Rouge General/Penington | Baton Rouge | Louisiana | 70809 | — |
| Annapolis Oncology Center | Annapolis | Maryland | 21401 | — |
| Lapidus Cancer Center/Sinai Hospital | Baltimore | Maryland | 21215 | — |
| Kalamazoo Hematology & Oncology | Kalamazoo | Michigan | 49048 | — |
| VA Sierra Nevada Health Care System | Reno | Nevada | 89502 | — |
| VA Medical Center | Durham | North Carolina | — | — |
| Piedmont Hematology Oncology Associates, PLLC | Winston-Salem | North Carolina | 27103 | — |
| Cincinnati VA Medical Center | Cincinnati | Ohio | 45220 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | — | — |
| WJB Dorn VA Medical Center | Columbia | South Carolina | 29209 | — |
| ACORN | Memphis | Tennessee | 38120 | — |
| Mary Crowley Medical Research Center | Dallas | Texas | 75246 | — |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | — |
| Texas Oncology - Allison Cancer Center | Midland | Texas | 79701 | — |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00862134, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 10, 2013 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00862134 live on ClinicalTrials.gov.