Lung CancerPhase 2NCT00301808
Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer
A Phase 2 study testing Cisplatin, Docetaxel and Pemetrexed disodium in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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, Docetaxel and Pemetrexed disodium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2005to Oct 2012
- 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:
- Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:
- Stage IIIA disease, meeting all of the following criteria:
- Mediastinal lymph node involvement
- Greater than one mediastinal lymph node enlarged on CT scan, confirmed by positron emission tomography (PET) scan
- Paralyzed left vocal cord with separate lung primary distinct from the aorto-pulmonary lymph nodes on the CT scan
- Stage IIIB disease, meeting all of the following criteria:
- N3 lymph node involvement
- Enlarged N3 lymph nodes on CT scan confirmed by PET scan
- Lymph node involvement may not extend to cervical lymph nodes other than supraclavicular lymph nodes
- Right-sided primary tumor with left vocal cord paralysis
- Evidence of tumor extension into the mediastinum and/or mediastinal structures by mediastinoscopy, bronchoscopy, or CT scan
- No evidence of malignant pleural effusion unless effusion is only evident on CT scan
- No more than 1 parenchymal lesions on the same or opposite sides of the lung
- No brain metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
- SWOG performance status 0 or 1
- Platelet count ≥ 100,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Creatinine clearance ≥ 45 mL/min
- Bilirubin normal
- Transaminases (SGOT and/or SGPT) ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Total lung volume (i.e., right and left lung minus the gross tumor volume) receiving greater than 20 Gy of radiation ≤ 40%
- FEV_1 ≥ 70% of predicted
- DLCO ≥ 50 mL/min
- No other concurrent malignancy
- Prior malignancy allowed provided it is in clinical control and is not likely to impact clinical outcome in the opinion of the treating physician
- No peripheral neuropathy ≥ grade 2
- No serious medical illness, including, but not limited to, any of the following:
- Uncontrolled congestive heart failure
- Uncontrolled angina
- Myocardial infarction
- Cerebrovascular event within the past 6 months
- History of chronic active hepatitis
- History of HIV infection
- Active bacterial infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be willing and able to take folic acid, cyanocobalamin (vitamin B12), or dexamethasone
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for NSCLC
- No concurrent participation in another therapeutic investigational study
- Concurrent ibuprofen (400 mg four times daily) allowed during pemetrexed disodium administration provided the patient has normal renal function
- No concurrent aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) 2 days before, during, and for 2 days after pemetrexed disodium administration
- Patients on long-acting NSAIDs (e.g. naproxen sodium, diflunisal, nabumetone, or celecoxib) must be willing or able to discontinue usage 5 days prior to, during, and for 2 days after pemetrexed disodium administration
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201
About this study
Official title: Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by consolidation therapy with docetaxel.
Secondary
- Assess the progression-free survival and overall survival.
- Assess the toxicity of this regimen.
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses.
After completion of study therapy, patients are followed at 1 month and periodically thereafter.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Keywords
- 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
Also called Platin, Cisplatinum
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
DocetaxelDrug
Also called Taxotere®
Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodiumDrug
Also called Alimta
Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapyRadiation
Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin, Docetaxel & Radiation Therapy | Experimental | Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. Receives: Drug: Cisplatin; Drug: Docetaxel; Drug: Pemetrexed disodium; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of Overall Survival at One Year
Overall Survival at one year using Kaplan-Meier product-limit analysis
Measured: at 1 year
Secondary outcomes (3)
Progression-free Survival
Progression-free survival using Kaplan-Meier estimates
Measured: Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.
Overall Survival
Overall survival using Kaplan-Meier estimates
Measured: Date of registration to the date of death
Safety Outcomes
Toxicity: total number of SAEs and other AEs
Measured: 72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startNov 2005
- Primary completionSep 2012
- Study completionOct 2012
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.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Shirish M. Gadgeel, Barbara Ann Karmanos Cancer Institute
- Investigators
- Shirish M. Gadgeel, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301808
- Sponsor's protocol ID
- CDR0000461591
- Other IDs
- P30CA022453, WSU-D-2934, WSU-0507002542
- Status last verified
- Jul 2014
- First submitted
- 9 Mar 2006
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gadgeel SM, Ruckdeschel JC, Patel BB, Wozniak A, Konski A, Valdivieso M, Hackstock D, Chen W, Belzer K, Burger AM, Marquette L, Turrisi A. Phase II study of pemetrexed and cisplatin, with chest radiotherapy followed by docetaxel in patients with stage III non-small cell lung cancer. J Thorac Oncol. 2011 May;6(5):927-33. doi: 10.1097/JTO.0b013e3182156109.
PubMed 21415776
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)
- ClinicalTrials.gov ID
- NCT00301808
- Acronym / sponsor ID
- CDR0000461591
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2005
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Mar 2006 (estimated)
- Results
- Posted 13 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by consolidation therapy with docetaxel.
Secondary
- Assess the progression-free survival and overall survival.
- Assess the toxicity of this regimen.
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses.
After completion of study therapy, patients are followed at 1 month and periodically thereafter.
PROJECTED ACCRUAL: A total of 28 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 |
|---|---|---|
| Cisplatin, Docetaxel & Radiation Therapy | Experimental | Drug: Cisplatin, Drug: Docetaxel, Drug: Pemetrexed disodium, Radiation: Radiation therapyCisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. |
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 |
|---|---|---|
| CisplatinAlso: Platin, CisplatinumCisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43 | Drug | Cisplatin, Docetaxel & Radiation Therapy |
| DocetaxelAlso: Taxotere®Docetaxel 75 mg/m2 on day 1 of each cycle | Drug | Cisplatin, Docetaxel & Radiation Therapy |
| Pemetrexed disodiumAlso: AlimtaPemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43 | Drug | Cisplatin, Docetaxel & Radiation Therapy |
| Radiation therapyRadiation therapy will begin within 24 hours of the first cycle of chemotherapy. | Radiation | Cisplatin, Docetaxel & Radiation Therapy |
Primary outcome
Probability of Overall Survival at One Year
Time frame: at 1 year
Overall Survival at one year using Kaplan-Meier product-limit analysis
3 secondary outcomes
Progression-free Survival
Time frame: Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.
Overall Survival
Time frame: Date of registration to the date of death
Safety Outcomes
Time frame: 72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21415776Gadgeel SM, Ruckdeschel JC, Patel BB, Wozniak A, Konski A, Valdivieso M, Hackstock D, Chen W, Belzer K, Burger AM, Marquette L, Turrisi A. Phase II study of pemetrexed and cisplatin, with chest radiotherapy followed by docetaxel in patients with stage III non-small cell lung cancer. J Thorac Oncol. 2011 May;6(5):927-33. doi: 10.1097/JTO.0b013e3182156109.
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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.
Shirish M. Gadgeel, MD study chair
Barbara Ann Karmanos Cancer Institute
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, Docetaxel and Pemetrexed disodium in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute 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 6 May 2023. 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 13 May 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?
Probability of Overall Survival at One Year (time frame: at 1 year). 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 NCT00301808, 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 6 May 2023.