Lung CancerPhase 2NCT00227539
Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
A Phase 2 study testing cisplatin, pemetrexed disodium and adjuvant therapy in people with Lung Cancer, run by University of Washington at 2 sites in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- cisplatin, pemetrexed disodium and adjuvant therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Nov 2013
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IB, II, IIIA, or IIIB (T4, N0-1) disease
- Staging must have been performed 4 weeks prior to study entry with a CT scan of chest, upper abdomen, and fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET) scan
- Mediastinal evaluation and staging based on combination of CT scan and FDG-PET results
- If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by brain MRI
- Measurable and resectable disease
- T4 lesions must be resectable
- Eligible for curative surgery
- No malignant pleural effusion
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,250/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3.0 times ULN
Renal
- Creatinine clearance ≥ 45 mL/min
Pulmonary
- Adequate pulmonary reserve to undergo surgery
- Predicted FEV_1 > 0.8 L after resection
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Able to take corticosteroids
- Able to take folic acid or vitamin B_12 supplements
- No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer
- No concurrent serious or uncontrolled disorder that would preclude study participation
- No type I diabetes mellitus
- Type II diabetes mellitus allowed if glucose is 80-150 mg/dL
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No concurrent prophylactic filgrastim (G-CSF)
- No concurrent thrombopoiesis-stimulating agents
Chemotherapy
- At least 5 years since prior chemotherapy
Endocrine therapy
- No concurrent anticancer hormonal therapy
Radiotherapy
- No prior radiotherapy to the chest
- No concurrent curative or palliative radiotherapy
Surgery
- Not specified
Other
- At least 30 days since prior non-FDA-approved or investigational agents
- At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8 days for long-acting agents [e.g., piroxicam])
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
University of Washington School of Medicine
Seattle, Washington, 98195
About this study
Official title: Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well PET works in predicting response in patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without surgery for stage I, stage II, or stage III non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in predicting radiological and pathological response in patients treated with pemetrexed disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung cancer (NSCLC).
Secondary
- Determine the safety of cisplatin and pemetrexed disodium in these patients.
- Determine the radiographic response rate, duration of response, and time to progression in patients treated with cisplatin and pemetrexed disodium.
OUTLINE: This is a multicenter study.
- Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at three points during the study: 4 weeks prior to treatment, after the first cycle of treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical resection of the tumor.
- Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- cisplatin, pemetrexed disodium, adjuvant therapy, therapeutic conventional surgery, fludeoxyglucose F 18
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, 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
pemetrexed disodiumDrug
adjuvant therapyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
fludeoxyglucose F 18Radiation
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy, PET scan and surgery | Experimental | Not described Receives: Drug: cisplatin; Drug: pemetrexed disodium; Procedure: adjuvant therapy; Procedure: therapeutic conventional surgery; Radiation: fludeoxyglucose F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Measured: Between days 18 and 22 prior to second chemotherapy infusion
Secondary outcomes (2)
Safety of Neoadjuvant Chemotherapy
The number of patients that experienced a grade 3 or higher adverse event.
Measured: Up to 4 weeks after last dose of chemotherapy
Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate
The number of patients that had either a CR, PR or SD after the completion of chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Measured: Up to 4 weeks after last dose of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionMar 2010
- Study completionNov 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Renato Martins, University of Washington
- Investigators
- Renato Martins, MD, MPH, Principal investigator, Seattle Cancer Care Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227539
- Sponsor's protocol ID
- 6228
- Other IDs
- P30CA015704, UWCC-6228, UWCC-UW-6228, UW-04033, LILY-UW-04033, CDR0000441239
- Status last verified
- Feb 2017
- First submitted
- 26 Sep 2005
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Romine PE, Martins RG, Eaton KD, Wood DE, Behnia F, Goulart BHL, Mulligan MS, Wallace SG, Kell E, Bauman JE, Patel SA, Vesselle HJ. Long term follow-up of neoadjuvant chemotherapy for non-small cell lung cancer (NSCLC) investigating early positron emission tomography (PET) scan as a predictor of outcome. BMC Cancer. 2019 Jan 14;19(1):70. doi: 10.1186/s12885-019-5284-2.
PubMed 30642285
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00227539
- Acronym / sponsor ID
- 6228
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Sep 2005 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well PET works in predicting response in patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without surgery for stage I, stage II, or stage III non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in predicting radiological and pathological response in patients treated with pemetrexed disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung cancer (NSCLC).
Secondary
- Determine the safety of cisplatin and pemetrexed disodium in these patients.
- Determine the radiographic response rate, duration of response, and time to progression in patients treated with cisplatin and pemetrexed disodium.
OUTLINE: This is a multicenter study.
- Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at three points during the study: 4 weeks prior to treatment, after the first cycle of treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical resection of the tumor.
- Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy, PET scan and surgery | Experimental | Drug: cisplatin, Drug: pemetrexed disodium, Procedure: adjuvant therapy, Procedure: therapeutic conventional surgery, Radiation: fludeoxyglucose F 18 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | Drug | Neoadjuvant therapy, PET scan and surgery |
| pemetrexed disodium | Drug | Neoadjuvant therapy, PET scan and surgery |
| adjuvant therapy | Procedure or surgery | Neoadjuvant therapy, PET scan and surgery |
| therapeutic conventional surgery | Procedure or surgery | Neoadjuvant therapy, PET scan and surgery |
| fludeoxyglucose F 18 | Radiation | Neoadjuvant therapy, PET scan and surgery |
Primary outcome
Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Time frame: Between days 18 and 22 prior to second chemotherapy infusion
Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
2 secondary outcomes
Safety of Neoadjuvant Chemotherapy
Time frame: Up to 4 weeks after last dose of chemotherapy
Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate
Time frame: Up to 4 weeks after last dose of chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30642285Romine PE, Martins RG, Eaton KD, Wood DE, Behnia F, Goulart BHL, Mulligan MS, Wallace SG, Kell E, Bauman JE, Patel SA, Vesselle HJ. Long term follow-up of neoadjuvant chemotherapy for non-small cell lung cancer (NSCLC) investigating early positron emission tomography (PET) scan as a predictor of outcome. BMC Cancer. 2019 Jan 14;19(1):70. doi: 10.1186/s12885-019-5284-2.
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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.
Renato Martins, MD, MPH principal investigator
Seattle Cancer Care Alliance
2 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 cisplatin, pemetrexed disodium and adjuvant therapy in people with Lung Cancer, run by University of Washington at 2 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?
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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 Apr 2017). 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?
Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy (time frame: Between days 18 and 22 prior to second chemotherapy infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00227539, which also lists 1 linked publication.
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 9 May 2017.