Non-Small Cell Lung CancerPhase 1/2NCT00417248
Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer
A Phase 1/2 study testing Cisplatin, Etoposide and Radiotherapy in people with Non-Small Cell Lung Cancer, run by Nasser Hanna, M.D. at 8 sites in United States.
Trial summary
Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Cisplatin, Etoposide and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2007to Apr 2008
- Phase
- Phase 1/2
- 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
- Histological or cytological proof of non-small cell lung cancer (NSCLC).
- Measurable or non-measurable disease per RECIST.
- Unresectable Stage IIIA or IIIB disease as evaluated by imaging.
- Must be age ≥ 18 years at the time of consent.
- Written informed consent and HIPAA authorization for release of personal health information.
- Females of childbearing potential and males must be willing to use an effective method of contraception.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for initial therapy.
Who cannot join
- No prior chemotherapy or radiotherapy for lung cancer.
- No positive supraclavicular or scalene lymph nodes extending up into the cervical region.
- No superior sulcus (pancoast tumors).
- No malignant pleural effusions. The only exception is a patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR deemed too small to tap.
- No clinically significant or malignant pericardial effusions.
- No CNS metastases.
Show all 26Show fewer
- No unintended weight loss (> 5% body weight) in the preceding 90 days prior to registration for initial therapy.
- No treatment with any investigational agent within 30 days prior to being registered for initial therapy.
- No prior therapy with a Ras pathway inhibitor or anti-angiogenic agent.
- No other active cancers.
- Females must not be breastfeeding.
- No active clinically serious infections as judged by the treating investigator (> CTC v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- No major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for initial therapy.
- No anticipation of need for major surgical procedure during the course of the study.
- No minor surgical procedures such as fine needle aspirations or cone biopsies within 7 days prior to registration for initial therapy.
- No history of allergic reactions to drugs utilizing the vehicle polysorbate 80 + polyethylene glycol (etoposide).
- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for initial therapy.
- No use inhibitors or inducers of the cytochrome p450 system CYP3A4 enzyme or other medications such as aprepitant, ketoconazole, itraconazole, quinidine, digoxin, cyclosporine, ritonavir, grapefruit products, St. John's Wort, rifampin (rifampicin), carbamazepine, phenytoin, dexamethasone, and phenobarbital.
- No evidence or history of bleeding diathesis or coagulopathy.
- No serious non-healing wound, ulcer, or bone fracture.
- No known or suspected allergy to sorafenib.
- No uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management.
- No thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within 6 months prior to registration for initial therapy.
- No pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks prior to registration for initial therapy.
- No hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to registration for initial therapy.
- No condition that impairs patient's ability to swallow whole pills or any malabsorption problem.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Oncology Partners Network
Cincinnati, Ohio, 45247
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Horizon Oncology Center
Lafayette, Indiana, 47905
Medical Consultants, P.C.
Muncie, Indiana, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
About this study
Official title: A Phase II Trial of Concurrent Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN06-107
Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.
Read the detailed description
Outline: This is a multi-center study.
Chemotherapy/radiation therapy (2 cycles)
- Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle
- Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle
- Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) with the following:
Maintenance therapy of Sorafenib 400 mg PO BID of 28 day cycle, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 1 year.
Patients with progressive disease will discontinue treatment.
ECOG performance status 0 or 1
Hematopoietic:
- Absolute neutrophil count (ANC) ≥ 1500 mm3
- Platelet count ≥ 100,000 mm3
- Hemoglobin ≥ 9 g/dL
- PT or INR < 1.5 x ULN unless on anti-coagulant therapy
- PTT < 1.5 x ULN unless on anti-coagulant therapy
Hepatic:
- Bilirubin ≤ 1.5 x ULN
- ALT ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)
- AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)
Renal:
- Creatinine < 1.5 X upper limit of normal (ULN)
Cardiovascular:
- No significant history of cardiac disease: Congestive heart failure > class II NYHA.
- Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within 90 days prior to registration for initial therapy) or myocardial infarction within 6 months prior to registration for initial therapy.
Respiratory:
- FEV1 ≥ 1 liter by spirometry within 60 days prior to registration for initial therapy.
- Conditions
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
EtoposideDrug
Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
RadiotherapyProcedure or surgery
Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
SorafenibDrug
Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months
| Study group | Role | What they receive |
|---|---|---|
| Investigational Treatment | Experimental | Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer Receives: Drug: Cisplatin; Drug: Etoposide; Procedure: Radiotherapy; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression (TTP)
Measured: 18 months
Secondary outcomes (1)
Overall Survival
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2006 (estimated)
- Study startJun 2007
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Negative sorafenib results from ESCAPE trial and safety concerns of regimen
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 Non-Small Cell 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasser Hanna, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nasser Hanna, M.D., Hoosier Cancer Research Network
- Investigators
- Nasser Hanna, M.D., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417248
- Sponsor's protocol ID
- HOG LUN06-107
- Status last verified
- May 2016
- First submitted
- 28 Dec 2006
- Last updated
- 25 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Concurrent Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN06-107
- ClinicalTrials.gov ID
- NCT00417248
- Acronym / sponsor ID
- HOG LUN06-107
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Negative sorafenib results from ESCAPE trial and safety concerns of regimen
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Nasser Hanna, M.D.University, hospital or other
- Collaborators
- Bayer, Amgen, Walther Cancer Institute
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 29 Dec 2006 (estimated)
- Results
- Posted 25 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.
Detailed description
Outline: This is a multi-center study.
Chemotherapy/radiation therapy (2 cycles)
- Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle
- Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle
- Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) with the following:
Maintenance therapy of Sorafenib 400 mg PO BID of 28 day cycle, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 1 year.
Patients with progressive disease will discontinue treatment.
ECOG performance status 0 or 1
Hematopoietic:
- Absolute neutrophil count (ANC) ≥ 1500 mm3
- Platelet count ≥ 100,000 mm3
- Hemoglobin ≥ 9 g/dL
- PT or INR < 1.5 x ULN unless on anti-coagulant therapy
- PTT < 1.5 x ULN unless on anti-coagulant therapy
Hepatic:
- Bilirubin ≤ 1.5 x ULN
- ALT ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)
- AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)
Renal:
- Creatinine < 1.5 X upper limit of normal (ULN)
Cardiovascular:
- No significant history of cardiac disease: Congestive heart failure > class II NYHA.
- Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within 90 days prior to registration for initial therapy) or myocardial infarction within 6 months prior to registration for initial therapy.
Respiratory:
- FEV1 ≥ 1 liter by spirometry within 60 days prior to registration for initial therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Treatment | Experimental | Drug: Cisplatin, Drug: Etoposide, Procedure: Radiotherapy, Drug: SorafenibCisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological or cytological proof of non-small cell lung cancer (NSCLC).
- Measurable or non-measurable disease per RECIST.
- Unresectable Stage IIIA or IIIB disease as evaluated by imaging.
- Must be age ≥ 18 years at the time of consent.
- Written informed consent and HIPAA authorization for release of personal health information.
Key exclusion criteria (26 listed)
- No prior chemotherapy or radiotherapy for lung cancer.
- No positive supraclavicular or scalene lymph nodes extending up into the cervical region.
- No superior sulcus (pancoast tumors).
- No malignant pleural effusions. The only exception is a patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR deemed too small to tap.
- No clinically significant or malignant pericardial effusions.
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 |
|---|---|---|
| CisplatinCisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle | Drug | Investigational Treatment |
| EtoposideEtoposide 50 mg/m2 IV, days 1-5 of 28 day cycle | Drug | Investigational Treatment |
| RadiotherapyConcurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) | Procedure or surgery | Investigational Treatment |
| SorafenibMaintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months | Drug | Investigational Treatment |
Primary outcome
Time to Disease Progression (TTP)
Time frame: 18 months
1 secondary outcome
Overall Survival
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Nasser Hanna, M.D. study chair
Hoosier Oncology Group, LLC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cisplatin, Etoposide and Radiotherapy in people with Non-Small Cell Lung Cancer, run by Nasser Hanna, M.D. at 8 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 7 inclusion and 26 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 25 Jul 2016). 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?
Time to Disease Progression (TTP) (time frame: 18 months). 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 25 Jul 2016.