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A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

A randomized phase II, multi-center, open-label, study of docetaxel versus docetaxel/PR104.

Following informed consent, subjects will undergo baseline evaluation with history, physical
exams, blood work and disease assessment. Selected subjects will undergo PET imaging with
F18 fluoromisonidazole (F18-FMISO) and Fludeoxyglucose (FDG) for assessment of hypoxia and
glucose metabolism, and pharmacokinetics of PR104.

Subjects will be randomized between arm 1 consisting of docetaxel, 75 mg/m^2, administered
intravenously (IV), every 21 days (an approved dose and schedule) and arm 2 consisting of
docetaxel, 60 mg/m^2 with PR104 at 770 mg/m^2, IV, every 21 days. Subjects randomized to
PR104/docetaxel will receive prophylactic G-CSF. One cycle will be 21 days in duration.
Subjects will be evaluated weekly. A disease assessment will be performed every six weeks.
Subjects with progression will be removed from study. Subjects with a response or stable
disease may continue on study if this is considered beneficial by their physician.

Inclusion Criteria:

- Subjects with locally advanced or metastatic NSCLC (stage IIIb/IV) who have relapsed
following adjuvant or first line therapy with a platinum containing regimen, and are
appropriate candidates for treatment with single agent docetaxel

- Confirmed NSCLC by prior pathological analysis (tissue aspirate or biopsy)

- At least 21 days from prior chemotherapy

- At least 30 days from prior irradiation therapy

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy of 12 weeks or more

- Adequate hematologic function [Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
platelet count ≥100x10^9/L; hemoglobin ≥8.5 g /dL maintained in the absence of red
blood cell transfusions; and prothrombin time international normalized ratio ≤1.7; or
prothrombin time ≤2 seconds above control)

- Adequate hepatic function (albumin ≥2.8 g/dL; total bilirubin ≤2 mg/dL [51.3 μmol/L];
and alanine aminotransferase and aspartate aminotransferase ≤1.5 times the upper
limit of the normal range)

- Adequate renal function (serum creatinine ≤2.0 times the upper limit of the normal
range or creatinine clearance ≥60 mL/min).

- At least one untreated target lesion that could be measured in one dimension,
according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

- Previous treatment with docetaxel (prior treatment with paclitaxel permitted)

- Receipt of more than one prior systemic chemotherapy regimen

- Active concomitant malignancy likely to effect any of the primary or secondary
outcome measures in the current study

- Women who are pregnant, breast-feeding or planning to become pregnant during the

- Men or women of reproductive-potential who are unwilling to use an effective method
of contraception during the study and for 30 days following the last dose

- Evidence of a significant medical disorder or laboratory finding that, in the opinion
of the Investigator, compromises the subject's safety during study participation

- Active Central Nervous System (CNS) metastatic disease requiring intervention

- Less than 4 weeks since major surgery

- Known human immunodeficiency virus (HIV) positivity

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants That Achieved a Response (Complete or Partial) After Receiving PR104/Docetaxel Versus Docetaxel Alone

Outcome Description:

Defined as the number of subjects with complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Outcome Time Frame:

Participants were followed for the duration on study, an average of 4 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

May 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Midwestern Regional Medical Center Zion, Illinois  60099
Mary Crowley Medical Research Center Dallas, Texas  75246
University of Pennsylvania Philadelphia, Pennsylvania  19104
Northwestern University Chicago, Illinois  60611
Scott & White Memorial Hospital Temple,, Texas  76508
WJB Dorn VA Medical Center Columbia, South Carolina  29209
The Center for Cancer and Blood Disorders Fort Worth, Texas  76104
Annapolis Oncology Center Annapolis, Maryland  21401
Sharp Clinical Oncology Research San Diego, California  92123
Piedmont Hematology Oncology Associates, PLLC Winston-Salem, North Carolina  
VA Sierra Nevada Health Care System Reno, Nevada  89502
Cancer Center of Kansas Wichita, Kansas  67214
Kalamazoo Hematology & Oncology Kalamazoo, Michigan  49048
Montgomery Cancer Center Mt. Sterling, Kentucky  40353
ACORN Memphis, Tennessee  38138
VA Medical Center Durham, North Carolina  27705
Orchard Research, LLC Skokie, Illinois  60076
Texas Oncology - Allison Cancer Center Midland, Texas  79701
University of Miami/Sylvester Comprehensive Cancer Center Miami, Florida  33136
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
Baton Rouge General/Penington Baton Rouge, Louisiana  70809
Lapidus Cancer Center/Sinai Hospital Baltimore, Maryland  21215
Cincinnati VA Medical Center Cincinnati, Ohio  45220