Lung CancerPhase 2NCT00544674
PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer
A Phase 2 study testing PR104 and F-18-fluoromisonidazole in people with Lung Cancer, run by Proacta, Incorporated at 18 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- PR104 and F-18-fluoromisonidazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 18 sitesUnited States
- Study dates
- Aug 2007to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Measurable or evaluable disease
- 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
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 30 days after completion of study treatment
- See Disease Characteristics
- No concurrent prophylactic growth factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) during course 1 of study treatment
Who cannot join
- 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
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- PATIENT CHARACTERISTICS:
- Prior or concurrent malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or localized low-grade prostate cancer
- Hyponatremia (< 130 mmol/L)
- Evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the patient's safety during study participation, 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)
- Known human immunodeficiency virus (HIV) positivity, hepatitis B surface antigen-positivity, or hepatitis C positivity with abnormal liver function tests
- PRIOR CONCURRENT THERAPY:
- More than one prior chemotherapy regimen for SCLC
- Less than 24 hours from any prior radiotherapy or the likelihood of toxicity from prior radiotherapy
- Radiotherapy to > 25% of the bone marrow within the past 4 weeks
- Less than four weeks since major surgery
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Gabrail Cancer Center - Canton Office
Canton, Ohio, 44718
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45219
Good Samaritan Hospital Cancer Treatment Center
Cincinnati, Ohio, 45220
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Welborn Clinic
Evansville, Indiana, 47713
Front Range Cancer Specialists
Fort Collins, Colorado, 80524-4038
California Cancer Care, Incorporated - Greenbrae
Greenbrae, California, 94904-2007
Cancer and Blood Specialists of Nevada - Henderson
Henderson, Nevada, 89074
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435
Pacific Shores Medical Group - Long Beach
Long Beach, California, 90813
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, 40202
Peninsula Cancer Institute - Newport News Office
Newport News, Virginia, 23601
Purchase Cancer Group - Paducah
Paducah, Kentucky, 42001
Stanford Cancer Center
Stanford, California, 94305-5824
Arizona Clinical Research Center, Incorporated
Tucson, Arizona, 85715
About this study
Official title: A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer
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).
Read the detailed description
OBJECTIVES:
Primary
- Estimate the response rate of PR-104 in patients with treatment-naive or sensitive-relapse small cell lung cancer.
- Evaluate safety of this drug in these patients. Secondary
- Evaluate survival of these patients.
- Evaluate progression-free survival of these patients.
- Evaluate time to progression in these patients.
- Assess the pharmacokinetics (PK) of PR-104 and its alcohol metabolite.
- Estimate the rate of hypoxia using 18F-fluoromisonidazole (FMISO) positron emission topography (PET) imaging.
- Collect plasma samples for assessment of potential biomarkers of tumor hypoxia.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type (treatment-naive vs sensitive-relapse).
Patients receive PR-104 intravenously (IV) over 1 hour on day 1. Treatment repeats every 21 days for up to 4 courses (for treatment-naive patients) or in the absence of disease progression or unacceptable toxicity (for sensitive-relapse patients).
PK studies are performed during course 1 and after course 3. Blood is collected at baseline, during course 1, and at study completion for biomarker studies of tumor hypoxia (plasma proteins). Patients also undergo FMISO PET and fludeoxyglucose F18 (FDG) PET scans at baseline and after the second course of study therapy.
- Conditions
- Lung Cancer
- Being tested
- PR104, F-18-fluoromisonidazole
- Keywords
- extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PR104Drug
Also called PR-104
administered at a dose of 1100 mg/m^2 by intravenous infusion over 1 hour and repeated every three weeks
F-18-fluoromisonidazoleOther
Also called FMISO
administered intravenously prior to PET scan
| Study group | Role | What they receive |
|---|---|---|
| PR104 | Experimental | PR104 will be administered once every 21 days by IV Receives: Drug: PR104; Other: F-18-fluoromisonidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (Complete or Partial)
Measured: 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.
Measured: 30 days following the last administration of study treatment
Secondary outcomes (4)
Survival
Measured: Every 3 months for 2 years after discontinuation
Progression-free Survival
Progression free survival (PFS) is the time (days) from date of registration to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented.
Measured: 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
Time to progression (TTP) was defined as the time from date of registration to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
Measured: From registration of the first subject until radiological progression or recurrence whichever came first
Pharmacokinetics
Measured: Days 1 and 2 of Cycles 1 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJan 2009
Why it stopped: Terminated early due to discovery of new mechanism of activation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proacta, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544674
- Sponsor's protocol ID
- PR104-2001
- Other IDs
- PROACTA-PR-104-2001
- Status last verified
- Dec 2012
- First submitted
- 13 Oct 2007
- Last updated
- 10 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00544674
- Acronym / sponsor ID
- PR104-2001
- Conditions
- Lung Cancer
- Keywords
- extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early due to discovery of new mechanism of activation.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Proacta, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Posted 7 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
OBJECTIVES:
Primary
- Estimate the response rate of PR-104 in patients with treatment-naive or sensitive-relapse small cell lung cancer.
- Evaluate safety of this drug in these patients. Secondary
- Evaluate survival of these patients.
- Evaluate progression-free survival of these patients.
- Evaluate time to progression in these patients.
- Assess the pharmacokinetics (PK) of PR-104 and its alcohol metabolite.
- Estimate the rate of hypoxia using 18F-fluoromisonidazole (FMISO) positron emission topography (PET) imaging.
- Collect plasma samples for assessment of potential biomarkers of tumor hypoxia.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type (treatment-naive vs sensitive-relapse).
Patients receive PR-104 intravenously (IV) over 1 hour on day 1. Treatment repeats every 21 days for up to 4 courses (for treatment-naive patients) or in the absence of disease progression or unacceptable toxicity (for sensitive-relapse patients).
PK studies are performed during course 1 and after course 3. Blood is collected at baseline, during course 1, and at study completion for biomarker studies of tumor hypoxia (plasma proteins). Patients also undergo FMISO PET and fludeoxyglucose F18 (FDG) PET scans at baseline and after the second course of study therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PR104 | Experimental | Drug: PR104, Other: F-18-fluoromisonidazolePR104 will be administered once every 21 days by IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- Measurable or evaluable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (22 listed)
- 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:
- Prior or concurrent malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or localized low-grade prostate cancer
- Hyponatremia (< 130 mmol/L)
- Evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the patient's safety during study participation, including any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PR104Also: PR-104administered at a dose of 1100 mg/m^2 by intravenous infusion over 1 hour and repeated every three weeks | Drug | PR104 |
| F-18-fluoromisonidazoleAlso: FMISOadministered intravenously prior to PET scan | Other | PR104 |
Primary outcome
Response Rate (Complete or Partial)
Time frame: From registration until disease progression/recurrence
Safety and Tolerability: the Number of Subjects Experiencing a Serious Adverse Events
Time frame: 30 days following the last administration of study treatment
The number of participants with at least one Serious Adverse Event was measured.
4 secondary outcomes
Survival
Time frame: Every 3 months for 2 years after discontinuation
Progression-free Survival
Time frame: 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
Time frame: From registration of the first subject until radiological progression or recurrence whichever came first
Pharmacokinetics
Time frame: Days 1 and 2 of Cycles 1 and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PR104 and F-18-fluoromisonidazole in people with Lung Cancer, run by Proacta, Incorporated at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (Complete or Partial) (time frame: From registration until disease progression/recurrence). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2012.