Carcinoma, Non-Small-Cell Lung (NSCLC)Phase 2NCT00735904
Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing AG-013736, gemcitabine and cisplatin in people with Carcinoma, Non-Small-Cell Lung (NSCLC), run by Pfizer at 10 sites in 4 countries.
Trial summary
This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung (NSCLC)
- What is being tested?
- AG-013736, gemcitabine and cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Dec 2008to Nov 2011
- 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
- Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
- Candidate for primary treatment with cisplatin and gemcitabine
- Presence of measurable disease by RECIST
- Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1
Who cannot join
- Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
- One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
- History of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
- NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
- Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
- Untreated brain metastases.
- Need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), NSAID or other medications known to inhibit platelet function.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Ukraine4 sites
Pfizer Investigational Site
Dnipropetrovsk, 49102
Pfizer Investigational Site
Donetsk, 83092
Pfizer Investigational Site
Kyiv, 04107
Pfizer Investigational Site
Lviv, 79031
Romania3 sites
Pfizer Investigational Site
Bucharest, 022328
Pfizer Investigational Site
Cluj-Napoca, Cluj, 400015
Pfizer Investigational Site
Oradea, 410032
Poland2 sites
Pfizer Investigational Site
Torun, 87-100
Pfizer Investigational Site
Wodzislaw Sl., 44-300
About this study
Official title: Phase 2 Trial Of AG-013736 As First-Line Treatment For Patients With Squamous Non-Small Cell Lung Cancer Receiving Treatment With Cisplatin And Gemcitabine
This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung (NSCLC)
- Being tested
- AG-013736, gemcitabine, cisplatin
- Keywords
- AG-013736, axitinib, cisplatin, gemcitabine, NSCLC, squamous cell, lung cancer
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-013736Drug
Also called axitinib
AG-013736 5 mg tablets orally, twice daily, until disease progression
gemcitabineDrug
200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles
cisplatinDrug
1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| AG-013736/Cisplatin/Gemcitabine | Experimental | Not described Receives: Drug: AG-013736; Drug: gemcitabine; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Objective Response (OR)
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.
Measured: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)
Secondary outcomes (3)
Overall Survival (OS)
Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Measured: Baseline until death or assessed every 2 months (up to 28 days after the last dose)
Progression Free Survival (PFS)
Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Measured: Baseline, assessed every 2 months (up to 28 days after the last dose)
Duration of Response (DR)
Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Measured: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2011
- Study completionNov 2011
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 Carcinoma, Non-Small-Cell Lung (NSCLC)Studies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735904
- Sponsor's protocol ID
- A4061038
- Status last verified
- Nov 2012
- First submitted
- 13 Aug 2008
- Last updated
- 3 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bondarenko IM, Ingrosso A, Bycott P, Kim S, Cebotaru CL. Phase II study of axitinib with doublet chemotherapy in patients with advanced squamous non-small-cell lung cancer. BMC Cancer. 2015 May 1;15:339. doi: 10.1186/s12885-015-1350-6.
PubMed 25929582
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial Of AG-013736 As First-Line Treatment For Patients With Squamous Non-Small Cell Lung Cancer Receiving Treatment With Cisplatin And Gemcitabine
- ClinicalTrials.gov ID
- NCT00735904
- Acronym / sponsor ID
- A4061038
- Conditions
- Carcinoma, Non-Small-Cell Lung (NSCLC)
- Keywords
- AG-013736, axitinib, cisplatin, gemcitabine, NSCLC, squamous cell, lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Posted 3 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AG-013736/Cisplatin/Gemcitabine | Experimental | Drug: AG-013736, Drug: gemcitabine, Drug: cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
- Candidate for primary treatment with cisplatin and gemcitabine
- Presence of measurable disease by RECIST
- Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1
Key exclusion criteria (7 listed)
- Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
- One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
- History of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
- NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
- Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
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 |
|---|---|---|
| AG-013736Also: axitinibAG-013736 5 mg tablets orally, twice daily, until disease progression | Drug | AG-013736/Cisplatin/Gemcitabine |
| gemcitabine200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles | Drug | AG-013736/Cisplatin/Gemcitabine |
| cisplatin1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles | Drug | AG-013736/Cisplatin/Gemcitabine |
Primary outcome
Percentage of Participants With Objective Response (OR)
Time frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.
3 secondary outcomes
Overall Survival (OS)
Time frame: Baseline until death or assessed every 2 months (up to 28 days after the last dose)
Progression Free Survival (PFS)
Time frame: Baseline, assessed every 2 months (up to 28 days after the last dose)
Duration of Response (DR)
Time frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25929582Bondarenko IM, Ingrosso A, Bycott P, Kim S, Cebotaru CL. Phase II study of axitinib with doublet chemotherapy in patients with advanced squamous non-small-cell lung cancer. BMC Cancer. 2015 May 1;15:339. doi: 10.1186/s12885-015-1350-6.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AG-013736, gemcitabine and cisplatin in people with Carcinoma, Non-Small-Cell Lung (NSCLC), run by Pfizer at 10 sites in 4 countries.
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 4 inclusion and 7 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 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Ukraine, Romania, Poland, South Africa. 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 3 Jan 2013). 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?
Percentage of Participants With Objective Response (OR) (time frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)). 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 NCT00735904, 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 3 Jan 2013.