Unresectable Locally Advanced NSCLCPhase 2NCT00682383
Combined Modality Therapy With Growth Factor Support in Locally Advanced Non-small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta in people with Unresectable Locally Advanced NSCLC, run by Mt. Sinai Medical Center, Miami at 1 site in United States.
Trial summary
To determine the safety and efficacy of administering filgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgrastim with consolidation chemotherapy in patients with unresectable locally advanced NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Unresectable Locally Advanced NSCLC
- What is being tested?
- Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed NSCLC: Either histologic or cytologic proof of a newly diagnosed non-small cell lung cancer is required. A biopsy with histology is preferred, but cytology is allowed. Histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., a second biopsy will not be required).
- Patients with two or more parenchymal lesions on same or opposite sides of the lung are ineligible.
- Must have unresectable Stage IIIA (N2) or IIIB disease and also satisfy the following criteria:
- Unresectable Stage IIIA (N2) patients:
- N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or X-ray, such that, in the opinion of the treating investigator, the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection.
- N2 status must be documented by any one of the following methods:
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- Histologic or cytologic proof of N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Wang needle biopsy, fine needle aspiration under bronchoscopic or CT guidance or other method
- Node positivity by PET scan
- Nodes >2 cm on CT scan
- Paralyzed left true vocal cord with separate left lung primary distinct from AP window nodes on CT Scan
- Stage IIIB patients:
- Pathologic documented or radiographically documented positive N3 nodes.
- Patients with positive supraclavicular or scalene lymph nodes must not have disease extending up into the cervical region evidenced by one of the following:
- Fine needle aspiration, core needle biopsy or excisional biopsy of supraclavicular N3 nodes
- Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy
- Fine needle aspiration, core needle or Wang needle biopsy under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes
- Contralateral mediastinal nodes >2 cm on CT scan
- Contralateral node positivity on PET scan
- Right sided primary with paralyzed left true vocal cord
- Any of the following T4 lesions: Tumor of any size that invades any of the following: mediastinum, heart, great vessels, trachea, esophagus, vertebral body or carina:
- Written documentation of type of T4 extent by attending surgeon if the patient has had an exploratory thoracotomy or thoracoscopy
- T4 involvement of the trachea or carina by direct bronchoscopic visualization
- T4 involvement of the heart, esophagus, aorta, or vertebral body documented by CT scan, MRI or transesophageal ultrasound
- T4 involvement of the mediastinum may also be accepted by CT or MRI criteria if, in absence of the above organ involvement, there is a soft tissue extension directly into the mediastinal space.
- Radiographic criteria for involvement of main pulmonary artery or vein is allowed only if there is a mediastinal soft tissue mass.
- Age > 18 years
- ECOG performance status 0 or 1
- Ability to give informed consent
- Adequate organ and marrow function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
- WBC > 4,000/µL
- Absolute neutrophil count > 1,500/mm3
- Platelet count > 100 x 103 cells/mm3
- Bilirubin < 1.5 x institutional ULN
- AST or ALT < 2.5 x institutional ULN
- Alkaline Phosphatase <2.5 x institutional ULN
- Serum Creatinine < 2.0mg/dL and/or adequate creatinine clearance
- Adequate pulmonary function (FEV>1.5 liters, or if <1.5 liters, the predicted FEV1of the contralateral lung must be >800 cc based on the quantitative split function testing. (Predicted FEV1= FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report)
- Must have one measurable lesion by chest X-ray or CT scan. Lesion(s) must be accurately measured in at least one dimension (longest diameter to be recorded) as >20mm with conventional techniques or as >10mm with spiral CT scan
- Men and women of childbearing potential must agree to use effective contraception while on treatment and for 6 months after treatment
Who cannot join
- Malignant pleural or pericardial effusion
- Prior chemotherapy or radiation therapy
- Pregnant or lactating females
- Primary malignancy other than basal or squamous carcinoma of the skin or carcinoma in situ of the cervix, or any other cancer for which the patient has been disease free for five years. Other in situ malignancies (e.g. breast, bladder, etc) in the past 3 years are permissible
- Unintentional weight loss >10% body weight within the last 3 months
- Unable to provide informed consent
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- Any pre-malignant myeloid condition or any malignancy with myeloid characteristics
- Active infection
- Known hypersensitivity to E. coli-derived proteins, pegfilgrastim, Filgrastim, or any other component of the product
- Significant nonmalignant disease including: documented HIV infection; uncontrolled heart disease, and poorly controlled diabetes
- Treatment within the last 30 days with any experimental agent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
Miami Beach, Florida, 33140
About this study
Official title: Phase II Trial of Combined Modality Therapy With Growth Factor Support in Locally Advanced NSCLC
To determine the safety and efficacy of administering filgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgrastim with consolidation chemotherapy in patients with unresectable locally advanced NSCLC patients.
- Conditions
- Unresectable Locally Advanced NSCLC
- Being tested
- Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta
- Keywords
- Advanced NSCLC, Lung Cancer, Mount Sinai Medical Center CCOP
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin; Etoposide; Radiation therapy; Docetaxel; NeulastaDrug
Cisplatin 75 mg/m2 day 1 and 22
Etoposide 80mg/m2 days 1-3, 22-24
Radiation therapy: (initial fields 1.8gy/day (5 weeks) to 45Gy, then boost 2.0Gy/day (8 days) to a total of 61Gy) beginning day 1 (Total elapsed time: approximately 6 weeks, 3 days)
Filgrastim 5µg/kg* SQ injection days 4-13 and days 25-34
Docetaxel 75mg/m2 Q 3 Weeks X 3 Cycles
Pegfilgrastim 6 mg SQ injection day 2 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Other | Cisplatin 75 mg/m2 day 1 and 22
Etoposide 80mg/m2 days 1-3, 22-24
Radiation therapy: (initial fields 1.8gy/day (5 weeks) to 45Gy, then boost 2.0Gy/day (8 days) to a total of 61Gy) beginning day 1 (Total elapsed time: approximately 6 weeks, 3 days)
Filgrastim 5µg/kg* SQ injection days 4-13 and days 25-34
Docetaxel 75mg/m2 Q 3 Weeks X 3 Cycles
Pegfilgrastim 6 mg SQ injection day 2 of each cycle Receives: Drug: Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and efficacy of administering pegfilgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgramstim with consolidation chemotherapy in patients with unresectable locally advanced NSCLC patients.
Measured: One year
Secondary outcomes (1)
To determine the frequency of dose reductions, dose delays, and dose omissions during chemoradiotherapy with filgrastim and consolidation therapy with pegfilgrastim.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startSep 2003
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Locally Advanced NSCLCStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mt. Sinai Medical Center, Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Rogerio Lilenbaum, M.D., Mt. Sinai Medical Center, Miami
- Investigators
- Rogerio Lilenbaum, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682383
- Sponsor's protocol ID
- LUN 07
- Status last verified
- Oct 2012
- First submitted
- 20 May 2008
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Combined Modality Therapy With Growth Factor Support in Locally Advanced NSCLC
- ClinicalTrials.gov ID
- NCT00682383
- Acronym / sponsor ID
- LUN 07
- Conditions
- Unresectable Locally Advanced NSCLC
- Keywords
- Advanced NSCLC, Lung Cancer, Mount Sinai Medical Center CCOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mt. Sinai Medical Center, MiamiUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Sep 2003
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of administering filgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgrastim with consolidation chemotherapy in patients with unresectable locally advanced NSCLC patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Other | Drug: Cisplatin; Etoposide; Radiation therapy; Docetaxel; NeulastaCisplatin 75 mg/m2 day 1 and 22 Etoposide 80mg/m2 days 1-3, 22-24 Radiation therapy: (initial fields 1.8gy/day (5 weeks) to 45Gy, then boost 2.0Gy/day (8 days) to a total of 61Gy) beginning day 1 (Total elapsed time: approximately 6 weeks, 3 days) Filgrastim 5µg/kg* SQ injection days 4-13 and days 25-34 Docetaxel 75mg/m2 Q 3 Weeks X 3 Cycles Pegfilgrastim 6 mg SQ injection day 2 of each cycle |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Histologically or cytologically confirmed NSCLC: Either histologic or cytologic proof of a newly diagnosed non-small cell lung cancer is required. A biopsy with histology is preferred, but cytology is allowed. Histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., a second biopsy will not be required).
- Patients with two or more parenchymal lesions on same or opposite sides of the lung are ineligible.
- Must have unresectable Stage IIIA (N2) or IIIB disease and also satisfy the following criteria:
- Unresectable Stage IIIA (N2) patients:
- Stage IIIB patients:
Key exclusion criteria (11 listed)
- Malignant pleural or pericardial effusion
- Prior chemotherapy or radiation therapy
- Pregnant or lactating females
- Primary malignancy other than basal or squamous carcinoma of the skin or carcinoma in situ of the cervix, or any other cancer for which the patient has been disease free for five years. Other in situ malignancies (e.g. breast, bladder, etc) in the past 3 years are permissible
- Unintentional weight loss >10% body weight within the last 3 months
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 |
|---|---|---|
| Cisplatin; Etoposide; Radiation therapy; Docetaxel; NeulastaCisplatin 75 mg/m2 day 1 and 22 Etoposide 80mg/m2 days 1-3, 22-24 Radiation therapy: (initial fields 1.8gy/day (5 weeks) to 45Gy, then boost 2.0Gy/day (8 days) to a total of 61Gy) beginning day 1 (Total elapsed time: approximately 6 weeks, 3 days) Filgrastim 5µg/kg* SQ injection days 4-13 and days 25-34 Docetaxel 75mg/m2 Q 3 Weeks X 3 Cycles Pegfilgrastim 6 mg SQ injection day 2 of each cycle | Drug | ARM 1 |
Primary outcome
To determine the safety and efficacy of administering pegfilgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgramstim with consolidation chemotherapy in patients with unresectable locally advanced NSCLC patients.
Time frame: One year
1 secondary outcome
To determine the frequency of dose reductions, dose delays, and dose omissions during chemoradiotherapy with filgrastim and consolidation therapy with pegfilgrastim.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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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.
Rogerio Lilenbaum, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta in people with Unresectable Locally Advanced NSCLC, run by Mt. Sinai Medical Center, Miami at 1 site 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 39 inclusion and 11 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: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the safety and efficacy of administering pegfilgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgramstim with consolidation chemotherapy in patients with unresectable locally advanced NSCLC patients. (time frame: One year). 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 30 Oct 2012.