Non-small-Cell Lung CarcinomaPhase 2NCT00232206
Trial of Neoadjuvant Docetaxel and Cisplatin for Resectable Non-Small Cell Lung Cancer
A Phase 2 study testing Neoadjuvant Therapy with Cisplatin Plus Docetaxel in people with Non-small-Cell Lung Carcinoma, run by Providence Health & Services at 1 site in United States.
Trial summary
The primary objective of this study is to assess the response rate of treatment with two cycles of cisplatin and docetaxel chemotherapy prior to surgery (neoadjuvant) for early stage non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-Cell Lung Carcinoma
- What is being tested?
- Neoadjuvant Therapy with Cisplatin Plus Docetaxel
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Nov 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed NSCLC appropriate for surgery
- Medically fit for resection by lobectomy or pneumonectomy
- T1-2N1 disease by CT must have negative N2/N3 nodes by PET
- T3N1 disease must have pathologically negative N2/N3 nodes
- Measurable disease
- Patients must not be receiving other investigational therapy
Show all 15Show fewer
- Prior surgery for NSCLC okay if resected > or = 5 years prior
- No prior chemotherapy or radiation for NSCLC
- No uncontrolled medical problems
- No factors that would preclude obtaining informed consent
- Age 18 or greater
- Performance status (PS) 0-1
- Peripheral neuropathy must be < grade 1
- Acceptable hematologic and chemistry parameters
- Renal: creatinine clearance (calculated) > 50 cc/min
Who cannot join
- History of severe hypersensitivity to docetaxel or like drugs
- Pregnant or nursing women
- Prior chemotherapy or radiation for NSCLC
- Symptomatic superior sulcus tumors
- Prior malignancy except for treated non-melanoma skin cancer, in situ cervical cancer, localized prostate cancer or cancer from which the patient has been disease free for greater than three years
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: A Phase II Study of Cisplatin Plus Docetaxel as Neoadjuvant Therapy for Stages IB Through Selected IIIA NSCLC
The primary objective of this study is to assess the response rate of treatment with two cycles of cisplatin and docetaxel chemotherapy prior to surgery (neoadjuvant) for early stage non-small cell lung cancer (NSCLC). Secondary objectives of this study include assessment of radiographic response rate by computed tomography (CT) scanning, overall survival, time to progression, rate of complete surgical removal, and adverse reactions. In addition, this study will test whether positron emission tomography (PET) imaging can predict a tumor response. Patients who have a response to chemotherapy may receive 2 additional cycles after recovering from surgery.
Read the detailed description
Non-small cell lung cancer (NSCLC) accounts for 80% of new lung cancer diagnoses in the US. Surgery is the primary most successful treatment for early stage patients. However, even lung cancers caught at an early stage (stage IB through selected IIIA) have 5 year survivals after surgery at a rate of only 10-60%. Postoperative platinum based chemotherapy offers a 4-15% survival benefit, depending on stage in fit patients after complete surgical removal of early stage disease. Preoperative platinum based chemotherapy has been shown in small randomized trials to benefit patients with stage IIIA, N2 positive disease, but is not standard of care in earlier stage disease, such as the population in this study.
The combination of cisplatin and docetaxel is approved in the US for front line therapy of stage IV NSCLC based on randomized clinical data showing efficacy and manageable toxicity. Given the efficacy and tolerance of this combination in the metastatic setting, this regimen is an obvious choice for study in the neoadjuvant setting.
PET imaging is approved in the US for determining size, site and spread of lung cancer (staging) and has been shown to reduce unnecessary surgery when used as part of preoperative evaluation. Because NSCLC is not 100% responsive to chemotherapy and CT scans may not show a change in tumor size until after several cycles of chemotherapy, PET imaging might be an effective way to provide an earlier and more reliable estimate of response.
Preoperative chemotherapy will be given for a total of two cycles 21 days apart if any adverse events have resolved and there is no evidence of disease progression. Patients will undergo CT chest through liver and PET scans for restaging following the second cycle and will then be scheduled for surgery 3-6 weeks after the second cycle of chemotherapy. Patients who have responded according to CT and/or PET imaging, or surgical pathology will go on to receive an additional two cycles of chemotherapy with docetaxel and cisplatin once the patient has recovered from surgery.
- Conditions
- Non-small-Cell Lung Carcinoma
- Being tested
- Neoadjuvant Therapy with Cisplatin Plus Docetaxel
- Keywords
- NSCLC, Lung, Cancer, Metastatic, Neoadjuvant, Stage IB Non-Small Cell Lung Cancer (NSCLC), IIA Non-Small Cell Lung Cancer (NSCLC), IIB Non-Small Cell Lung Cancer (NSCLC), Some IIIA Non-Small Cell Lung Cancer (NSCLC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Therapy with Cisplatin Plus DocetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective: To assess the pathologic complete and partial response rate to neoadjuvant treatment with two cycles of cisplatin and docetaxel chemotherapy prior to resection of early stage NSCLC
Secondary outcomes (2)
Secondary objectives: Assessment of radiographic response rate by CT scanning, overall survival, time to progression, rate of complete surgical resection and toxicity
Evaluation of the predictive power of PET to define pathologic response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startMay 2005
- Primary completionApr 2007
- Study completionNov 2007
Why it stopped: study terminated due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-Cell Lung CarcinomaStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Cancer Center, Earle A. Chiles Research Institute, Sanofi
- Investigators
- Brendan Curti, MD, Principal investigator, Director, Lung Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232206
- Sponsor's protocol ID
- PPMC-EACRI-IRB-05-032
- Other IDs
- IIT #12207
- Status last verified
- May 2011
- First submitted
- 30 Sep 2005
- Last updated
- 18 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cisplatin Plus Docetaxel as Neoadjuvant Therapy for Stages IB Through Selected IIIA NSCLC
- ClinicalTrials.gov ID
- NCT00232206
- Acronym / sponsor ID
- PPMC-EACRI-IRB-05-032
- Conditions
- Non-small-Cell Lung Carcinoma
- Keywords
- NSCLC, Lung, Cancer, Metastatic, Neoadjuvant, Stage IB Non-Small Cell Lung Cancer (NSCLC), IIA Non-Small Cell Lung Cancer (NSCLC), IIB Non-Small Cell Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated due to slow accrual
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Providence Cancer Center, Earle A. Chiles Research Institute, Sanofi
- Study start
- May 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Nov 2007
- First posted
- 4 Oct 2005 (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.
The primary objective of this study is to assess the response rate of treatment with two cycles of cisplatin and docetaxel chemotherapy prior to surgery (neoadjuvant) for early stage non-small cell lung cancer (NSCLC). Secondary objectives of this study include assessment of radiographic response rate by computed tomography (CT) scanning, overall survival, time to progression, rate of complete surgical removal, and adverse reactions. In addition, this study will test whether positron emission tomography (PET) imaging can predict a tumor response. Patients who have a response to chemotherapy may receive 2 additional cycles after recovering from surgery.
Detailed description
Non-small cell lung cancer (NSCLC) accounts for 80% of new lung cancer diagnoses in the US. Surgery is the primary most successful treatment for early stage patients. However, even lung cancers caught at an early stage (stage IB through selected IIIA) have 5 year survivals after surgery at a rate of only 10-60%. Postoperative platinum based chemotherapy offers a 4-15% survival benefit, depending on stage in fit patients after complete surgical removal of early stage disease. Preoperative platinum based chemotherapy has been shown in small randomized trials to benefit patients with stage IIIA, N2 positive disease, but is not standard of care in earlier stage disease, such as the population in this study.
The combination of cisplatin and docetaxel is approved in the US for front line therapy of stage IV NSCLC based on randomized clinical data showing efficacy and manageable toxicity. Given the efficacy and tolerance of this combination in the metastatic setting, this regimen is an obvious choice for study in the neoadjuvant setting.
PET imaging is approved in the US for determining size, site and spread of lung cancer (staging) and has been shown to reduce unnecessary surgery when used as part of preoperative evaluation. Because NSCLC is not 100% responsive to chemotherapy and CT scans may not show a change in tumor size until after several cycles of chemotherapy, PET imaging might be an effective way to provide an earlier and more reliable estimate of response.
Preoperative chemotherapy will be given for a total of two cycles 21 days apart if any adverse events have resolved and there is no evidence of disease progression. Patients will undergo CT chest through liver and PET scans for restaging following the second cycle and will then be scheduled for surgery 3-6 weeks after the second cycle of chemotherapy. Patients who have responded according to CT and/or PET imaging, or surgical pathology will go on to receive an additional two cycles of chemotherapy with docetaxel and cisplatin once the patient has recovered from surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed NSCLC appropriate for surgery
- Medically fit for resection by lobectomy or pneumonectomy
- T1-2N1 disease by CT must have negative N2/N3 nodes by PET
- T3N1 disease must have pathologically negative N2/N3 nodes
- Measurable disease
Key exclusion criteria (5 listed)
- History of severe hypersensitivity to docetaxel or like drugs
- Pregnant or nursing women
- Prior chemotherapy or radiation for NSCLC
- Symptomatic superior sulcus tumors
- Prior malignancy except for treated non-melanoma skin cancer, in situ cervical cancer, localized prostate cancer or cancer from which the patient has been disease free for greater than three years
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 |
|---|---|---|
| Neoadjuvant Therapy with Cisplatin Plus Docetaxel | Drug | – |
Primary outcome
Primary objective: To assess the pathologic complete and partial response rate to neoadjuvant treatment with two cycles of cisplatin and docetaxel chemotherapy prior to resection of early stage NSCLC
2 secondary outcomes
Secondary objectives: Assessment of radiographic response rate by CT scanning, overall survival, time to progression, rate of complete surgical resection and toxicity
Evaluation of the predictive power of PET to define pathologic response
Results and safety
The study was stopped early (reason given: study terminated due to slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
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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.
Brendan Curti, MD principal investigator
Director, Lung Research
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 Neoadjuvant Therapy with Cisplatin Plus Docetaxel in people with Non-small-Cell Lung Carcinoma, run by Providence Health & Services 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 15 inclusion and 5 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 18 May 2011. 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 was stopped early (reason given: study terminated due to slow accrual). Results are not available in the source record.
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?
Primary objective: To assess the pathologic complete and partial response rate to neoadjuvant treatment with two cycles of cisplatin and docetaxel chemotherapy prior to resection of early stage NSCLC. 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 18 May 2011.