Non-small Cell Lung CancerPhase 2NCT02157116
Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing cisplatin, Docetaxel and Pegfilgrastim in people with Non-small Cell Lung Cancer, run by Duke University at 1 site in United States.
Trial summary
Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. The two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. 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, Docetaxel and Pegfilgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2010
- 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
- Patients with documented stage III NSCLC (IIIA or IIIB, without malignant pleural/pericardial effusion) are eligible for enrollment if they are considered appropriate for treatment with chemotherapy, radiation, or surgery;
- IIIA: T1-3 N2 M0, T3 N1 M0
- IIIB: T4 N0-2 M0, T 1-4 N3 M0
- Measurable or evaluable disease
- Previously untreated with chemotherapy or radiotherapy for lung cancer;
- No brain metastases;
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- No prior XRT
- Performance status 0-2
- ≥18 years of age
- Informed Consent
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Bilirubin ≤ 1.5 x upper limit of normal for the institution (ULN)
- SGOT and SGPT ≤ 2.5 x ULN for the institution
- Creatinine ≤ 1.6 mg/dL
- Hemoglobin ≥ 8.0 g/dL
- Peripheral neuropathy ≤ grade 1
Who cannot join
- Known sensitivity to E. coli derived products (e.g. Filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A);
- Use of IV systemic antibiotics within 72 hours prior to chemotherapy;
- Known HIV infection
- Lithium or cytokines within 2 weeks prior of entry
- Additional concurrent investigational drugs
- History of myelodysplastic syndrome
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- Pregnant, nursing or having unprotected sex
- Not available for follow-up assessment
- Unable to comply with protocol procedures
- Illnesses that may compromise ability to give informed consent.
- Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Dose-Dense Induction/Neoadjuvant Chemotherapy in the Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer With Additional Genomic Analyses to Identify Signatures Predictive of Chemotherapy Response.
Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. The two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. This study is exploring the response to chemotherapy when these drugs are given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens to identify signatures that may predict chemotherapy sensitivity or resistance.
Read the detailed description
All patients will receive induction chemotherapy with cisplatin and docetaxel. Pegfilgrastim will be administered approximately 24 hours following the end of the day 1 chemotherapy infusion. Cycles will be repeated every 2 weeks for 3 cycles. Patients deemed to be resectable will undergo surgical resection followed by postoperative thoracic radiotherapy. Patients deemed inoperable will additionally receive concurrent chemoradiotherapy. Response, using radiographic and/or pathologic means, will identify two cohorts; responders and nonresponders.Gene expression profiling will then be performed on pre-treatment specimens to identify signatures that predict for chemotherapy sensitivity or resistance.
The target enrollment is 45 patients.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- cisplatin, Docetaxel, Pegfilgrastim
- Keywords
- Dose-Dense Chemotherapy
- 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
Also called Platinol
DocetaxelDrug
Also called Taxotere
PegfilgrastimDrug
Also called Neulasta
| Study group | Role | What they receive |
|---|---|---|
| Induction Chemotherapy | Experimental | Cisplatin 75mg/m2 IV days 1, 15, 29; Docetaxel 75mg/m2 IV days 1, 15, 29; and Pegfilgrastim 6mg SC day 2, 16, 30 Receives: Drug: cisplatin; Drug: Docetaxel; Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction Response
Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.
Measured: Between 2 and 3 weeks after induction
Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy
Measured: at the end of the study, estimated 2.5 years
Secondary outcomes (4)
Number of Grade III/IV Hematologic Adverse Events
Measured: During induction chemotherapy, approximately 6 weeks
Number of Grade III/IV Non-hematologic Adverse Events
Measured: During induction chemotherapy, approximately 6 weeks
Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction
Measured: During induction, approximately 6 weeks
Overall Survival
Measured: Approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2006
- Primary completionOct 2009
- Study completionJan 2010
Why it stopped: Insufficient accrual to meet analysis goals
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157116
- Sponsor's protocol ID
- Pro00004682
- Status last verified
- Jun 2014
- First submitted
- 29 May 2014
- Last updated
- 4 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Dense Induction/Neoadjuvant Chemotherapy in the Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer With Additional Genomic Analyses to Identify Signatures Predictive of Chemotherapy Response.
- ClinicalTrials.gov ID
- NCT02157116
- Acronym / sponsor ID
- Pro00004682
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Dose-Dense Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual to meet analysis goals
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- May 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Posted 4 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. The two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. This study is exploring the response to chemotherapy when these drugs are given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens to identify signatures that may predict chemotherapy sensitivity or resistance.
Detailed description
All patients will receive induction chemotherapy with cisplatin and docetaxel. Pegfilgrastim will be administered approximately 24 hours following the end of the day 1 chemotherapy infusion. Cycles will be repeated every 2 weeks for 3 cycles. Patients deemed to be resectable will undergo surgical resection followed by postoperative thoracic radiotherapy. Patients deemed inoperable will additionally receive concurrent chemoradiotherapy. Response, using radiographic and/or pathologic means, will identify two cohorts; responders and nonresponders.Gene expression profiling will then be performed on pre-treatment specimens to identify signatures that predict for chemotherapy sensitivity or resistance.
The target enrollment is 45 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction Chemotherapy | Experimental | Drug: cisplatin, Drug: Docetaxel, Drug: PegfilgrastimCisplatin 75mg/m2 IV days 1, 15, 29; Docetaxel 75mg/m2 IV days 1, 15, 29; and Pegfilgrastim 6mg SC day 2, 16, 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with documented stage III NSCLC (IIIA or IIIB, without malignant pleural/pericardial effusion) are eligible for enrollment if they are considered appropriate for treatment with chemotherapy, radiation, or surgery;
- IIIA: T1-3 N2 M0, T3 N1 M0
- IIIB: T4 N0-2 M0, T 1-4 N3 M0
- Measurable or evaluable disease
- Previously untreated with chemotherapy or radiotherapy for lung cancer;
Key exclusion criteria (11 listed)
- Known sensitivity to E. coli derived products (e.g. Filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A);
- Use of IV systemic antibiotics within 72 hours prior to chemotherapy;
- Known HIV infection
- Lithium or cytokines within 2 weeks prior of entry
- Additional concurrent investigational drugs
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 |
|---|---|---|
| cisplatinAlso: Platinol | Drug | Induction Chemotherapy |
| DocetaxelAlso: Taxotere | Drug | Induction Chemotherapy |
| PegfilgrastimAlso: Neulasta | Drug | Induction Chemotherapy |
Primary outcome
Induction Response
Time frame: Between 2 and 3 weeks after induction
Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.
Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy
Time frame: at the end of the study, estimated 2.5 years
4 secondary outcomes
Number of Grade III/IV Hematologic Adverse Events
Time frame: During induction chemotherapy, approximately 6 weeks
Number of Grade III/IV Non-hematologic Adverse Events
Time frame: During induction chemotherapy, approximately 6 weeks
Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction
Time frame: During induction, approximately 6 weeks
Overall Survival
Time frame: Approximately 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
- 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.
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, Docetaxel and Pegfilgrastim in people with Non-small Cell Lung Cancer, run by Duke University 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 17 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: stopped early, as of the sponsor's last update on 4 Jul 2014. 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?
Yes. Results are posted in the registry (first posted 4 Jul 2014). 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?
Induction Response (time frame: Between 2 and 3 weeks after induction). 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 4 Jul 2014.