Study Stopped
Terminated early due to discovery of new mechanism of activation.
PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer
A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer
2 other identifiers
interventional
5
1 country
18
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well PR-104 works in treating patients with previously untreated or relapsed small cell lung cancer (SCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lung-cancer
Started Aug 2007
Shorter than P25 for phase_2 lung-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 13, 2007
CompletedFirst Posted
Study publicly available on registry
October 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
July 7, 2011
CompletedDecember 10, 2012
December 1, 2012
11 months
October 13, 2007
June 13, 2011
December 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Response Rate (Complete or Partial)
From registration until disease progression/recurrence
Safety and Tolerability: the Number of Subjects Experiencing a Serious Adverse Events
The number of participants with at least one Serious Adverse Event was measured.
30 days following the last administration of study treatment
Secondary Outcomes (4)
Survival
Every 3 months for 2 years after discontinuation
Progression-free Survival
Tumor measurements and assessments based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria were performed 6 weeks after first dose and as dictated by subject's malignancy
Time to Progression
From registration of the first subject until radiological progression or recurrence whichever came first
Pharmacokinetics
Days 1 and 2 of Cycles 1 and 4
Study Arms (1)
PR104
EXPERIMENTALPR104 will be administered once every 21 days by IV
Interventions
administered at a dose of 1100 mg/m\^2 by intravenous infusion over 1 hour and repeated every three weeks
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- If patient is treatment-naive, then they must have extensive disease
- If patients are not treatment-naive, then they must be classified as sensitive-relapse with either extensive disease or limited disease
- Sensitive-relapse defined as disease that responded to first-line chemotherapy and relapsed more than 90 days following the last dose of first-line chemotherapy
- Limited disease SCLC defined as disease confined to the hemithorax of origin, mediastinum, and/or ipsilateral supraclavicular lymph nodes, which could be encompassed within a tolerable radiotherapy port
- Extensive disease defined as disease that does not fit the definition of limited disease as defined above
- Measurable or evaluable disease
You may not qualify if:
- Active central nervous system (CNS) metastases, defined as metastases to the CNS (symptomatic or non-symptomatic) that requires immediate treatment or that are likely to require treatment in the following 6 weeks
- Medical conditions requiring urgent intervention, including any of the following:
- Superior vena cava syndrome
- Lobar obstruction
- Spinal cord compression
- Liver metastases involving greater than one-third of the liver
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL (no red blood cell transfusions allowed)
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN (if liver metastases are present) or ≤ 2 x ULN (if liver metastases are absent)
- Serum creatinine ≤ 1.5 x ULN
- Not pregnant or nursing
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Arizona Clinical Research Center, Incorporated
Tucson, Arizona, 85715, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
California Cancer Care, Incorporated - Greenbrae
Greenbrae, California, 94904-2007, United States
Pacific Shores Medical Group - Long Beach
Long Beach, California, 90813, United States
Stanford Cancer Center
Stanford, California, 94305-5824, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80524-4038, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
Welborn Clinic
Evansville, Indiana, 47713, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, 40202, United States
Purchase Cancer Group - Paducah
Paducah, Kentucky, 42001, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Cancer and Blood Specialists of Nevada - Henderson
Henderson, Nevada, 89074, United States
Gabrail Cancer Center - Canton Office
Canton, Ohio, 44718, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital Cancer Treatment Center
Cincinnati, Ohio, 45220, United States
Peninsula Cancer Institute - Newport News Office
Newport News, Virginia, 23601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Decision to close study early based on new data showing that PR104A could also be activated under oxic conditions in tumors that express high levels of AKR1C3. SCLC does not express meaningful levels of the enzyme aldo keto reductase 1C3 (AKR1C3).
Results Point of Contact
- Title
- Director of Clinical Development
- Organization
- Proacta, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2007
First Posted
October 16, 2007
Study Start
August 1, 2007
Primary Completion
July 1, 2008
Study Completion
January 1, 2009
Last Updated
December 10, 2012
Results First Posted
July 7, 2011
Record last verified: 2012-12