PR-104 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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PR-104 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2009
Sponsored by: William R. Bliss Cancer Center at Mary Greeley Medical Center

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00840021

Purpose
RATIONALE: Drugs used in chemotherapy, such as PR-104 and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving PR-104 together with docetaxel is more effective than giving docetaxel alone in treating patients with lung cancer.

PURPOSE: This randomized phase II trial is studying how well giving PR-104 together with docetaxel works in treating patients with stage IIIB or stage IV non-small cell lung cancer.



Condition Intervention Phase
Lung Cancer
Drug: PR-104
Drug: docetaxel
Phase II




MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label
Official Title: A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Response rate (complete or partial response) [ Designated as safety issue: No ]



Secondary Outcome Measures:
Survival [ Designated as safety issue: No ]

Progression-free survival [ Designated as safety issue: No ]

Time to progression [ Designated as safety issue: No ]

Safety [ Designated as safety issue: Yes ]

Pharmacokinetics of docetaxel, PR-104, and PR-104 and its metabolites [ Designated as safety issue: No ]


Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: Experimental
Patients receive docetaxel IV over 1 hour on day 1. Drug: docetaxel
Given IV
Arm II: Experimental
Patients receive PR-104 IV over 1 hour and docetaxel IV over 1 hour on day 1. Drug: PR-104
Given IV
Drug: docetaxel
Given IV


Detailed Description:
OBJECTIVES:

Primary

Estimate the response rate in patients with stage IIIB-IV non-small cell lung cancer treated with PR-104 and docetaxel.
Secondary

Evaluate survival of patients treated with this regimen.
Evaluate progression-free survival of patients treated this with regimen.
Evaluate time to progression in patients treated with this regimen.
Evaluate safety of this regimen in these patients.
Evaluate the pharmacokinetics of PR-104 and its metabolites.
Evaluate the pharmacokinetics of docetaxel.
Evaluate tumor hypoxia using 18F-fluoromisonidazole PET imaging. imaging.
Collect plasma samples from these patients to assess potential biomarkers of tumor hypoxia.
OUTLINE: This is a multicenter study.

Patients are stratified according to time since last chemotherapy (< 3 months vs &#8805; 3 months) and best response to last chemotherapy (objective tumor response or stable disease vs progressive disease or unknown response). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive docetaxel IV over 1 hour on day 1.
Arm II: Patients receive PR-104 IV over 1 hour and docetaxel IV over 1 hour on day 1.
In both arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients in arm II undergo blood sample collection periodically for pharmacokinetics and biomarkers of tumor hypoxia. Some patients in both arms undergo PET imaging with 18F-fluoromisonidazole and fludeoxyglucose F 18 to assess tumor hypoxia and glucose metabolism.

After completion of study therapy, patients are followed at 30 days and then every 3 months thereafter.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer

Locally advanced or metastatic disease (stage IIIB-IV)
Relapsed following adjuvant or first-line therapy with a platinum-containing regimen
Candidate for treatment with single-agent docetaxel
At least one untreated target lesion that could be measured in one dimension according to RECIST
No active CNS metastatic disease requiring intervention
PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Life expectance &#8805; 12 weeks
ANC &#8805; 1,500/mm³
Platelet count &#8805; 100,000/mm³
Hemoglobin &#8805; 8.5 g/dL (no RBC transfusions allowed)
PT/INR &#8804; 1.7 OR PT &#8804; 2 seconds above control
Albumin &#8805; 2.8 g/dL
Total bilirubin &#8804; 2 mg/dL
ALT and AST &#8804; 1.5 times upper limit normal (ULN)
Serum creatinine &#8804; 2.0 times ULN OR creatinine clearance &#8805; 60 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 30 days after completion of study therapy
No known HIV positivity
No other active malignancy that is likely to affect any of the primary or secondary study outcome measures
No evidence of a significant medical disorder or laboratory finding that could compromise patients' safety, including any of the following:

Uncontrolled infection or infection requiring a concurrent parenteral antibiotic
Uncontrolled diabetes
Congestive heart failure
Myocardial infarction within the past 6 months
Chronic renal disease
Coagulopathy (excluding prophylactic anticoagulation)
PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior docetaxel (prior paclitaxel allowed)
No more than 1 prior systemic chemotherapy regimen
At least 21 days since prior chemotherapy
At least 30 days since prior radiotherapy
At least 4 weeks since prior major surgery
No non-steroidal anti-inflammatory agents within 24 hours before and after PR104 administration
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840021


Locations
United States, Iowa
William R. Bliss Cancer Center at Mary Greeley Medical Center Recruiting
Ames, Iowa, United States, 50010
Contact: Debra M. Prow, MD 515-239-4737

Sponsors and Collaborators
William R. Bliss Cancer Center at Mary Greeley Medical Center
Investigators
Investigator: Karissa Tranel Proacta, Incorporated

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Responsible Party: Proacta, Incorporated ( Regulatory Affairs Associate )
Study ID Numbers: CDR0000633615, MGMC-PR104-2003, PROACTA-PR104-2003
Study First Received: February 7, 2009
Last Updated: February 7, 2009
ClinicalTrials.gov Identifier: NCT00840021 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer



Study placed in the following topic categories:
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Antineoplastic Agents
Respiratory Tract Neoplasms
Therapeutic Uses
Neoplasms
Pharmacologic Actions
Neoplasms by Histologic Type



ClinicalTrials.gov processed this record on February 10, 2009


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