Non-Small Cell Lung CancerPhase 2ANGELNCT00434135
Alimta and Gemcitabine in Non-Small Cell Lung Cancer
A Phase 2 study testing gemcitabine plus pemetrexed, paclitaxel plus gemcitabine in people with Non-Small Cell Lung Cancer and Stage IIIB or IV, run by Southern Italy Cooperative Oncology Group at 1 site in Italy.
Trial summary
The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG regimen) in terms of toxicity and QoL Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Stage IIIB or IV
- What is being tested?
- gemcitabine plus pemetrexed, paclitaxel plus gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- May 2006to Oct 2008
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) NSCLC
- No previous adjuvant or palliative chemotherapy
- No previous radiotherapy
- Presence of at least one unidimensionally measurable lesion (Appendix 2)
- ECOG performance status of 0 or 1 (Appendix 3)
- Charlson score ≤ 2 (Appendix 4)
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- Adequate bone marrow function (absolute neutrophil count ≥ 2 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin level ≥ 100 g/L), and adequate liver function (bilirubin level < two times the upper limit of normal, AST and/or ALT < three times the upper limit of normal, prothrombin time < 1.5 times control), and creatinine clearance ≥ 60 ml/min.
- Absence of symptomatic CNS metastases (patients with cerebral metastases treated with brain irradiation may be included), severe cardiac arrhythmia or heart failure, second or third degree heart block or acute myocardial infarction within 4 months prior to study entry.
- No major surgery or pleurodesis within 14 days prior to enrollment.
- Life expectancy of at least 12 weeks.
- No previous or concurrent malignancy, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for more than 5 years.
- Written informed consent
Who cannot join
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
- Patients with clinically significant effusions.
- Any other malignancies within 5 years that could affect therapy evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized Trial Assessing the Combination of Gemcitabine and Pemetrexed in the First Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG regimen) in terms of toxicity and QoL
Read the detailed description
Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to receive: (a)PG regimen: paclitaxel 120 mg/sqm followed by gemcitabine 1,000 mg/sqm i.v. on days 1 \& 8 q 3 weeks; (b)GA regimen: gemcitabine 1,250 mg/sqm i.v. on day 1 (plus folinic acid 350 μg daily orally and vitamin B12 1,000 μg i.m. q 9 weeks), pemetrexed (Alimta®) 500 mg/sqm i.v. on day 8 followed by gemcitabine 1,250 mg/sqm, q 3 weeks.
- Conditions
- Non-Small Cell Lung Cancer, Stage IIIB or IV
- Being tested
- gemcitabine plus pemetrexed, paclitaxel plus gemcitabine
- Keywords
- gemcitabine, pemetrexed, non-small cell lung cancer
- 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.
gemcitabine plus pemetrexed, paclitaxel plus gemcitabineDrug
gemcitabine 1,250 mg/sqm days 1\&8 + pemetrexed 500 mg/sqm day 8 paclitaxel 120 mg/sqm + gemcitabine 1,000 mg/sqm days 1\&8
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Gemcitabine 1,250 mg/sqm days 1 and 8 + Alimta 500 mg/sqm day 8, every 3 weeks Receives: Drug: gemcitabine plus pemetrexed, paclitaxel plus gemcitabine |
| B | Active comparator | Paclitaxel 120 mg/sqm days 1 and 8 + Gemcitabine 1,000 mg/sqm days 1 and 8, every 3 weeks Receives: Drug: gemcitabine plus pemetrexed, paclitaxel plus gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of patients treated with the gemcitabine plus Alimta regimen
Measured: after 3 cycles
Secondary outcomes (2)
Safety of patients treated with gemcitabine plus Alimta regimen
Measured: at the end of treatment
Quality of life of patients treated with gemcitabine plus Alimta regimen
Measured: after 3 cyces
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startMay 2006
- Primary completionOct 2007
- Study completionOct 2008
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Italy Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Investigators
- Pasquale Comella, MD, Principal investigator, National Tumor Institute, Naples, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434135
- Sponsor's protocol ID
- SICOG trial 0506
- Acronym
- ANGEL
- Status last verified
- Feb 2009
- First submitted
- 9 Feb 2007
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial Assessing the Combination of Gemcitabine and Pemetrexed in the First Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00434135
- Acronym / sponsor ID
- ANGEL / SICOG trial 0506
- Conditions
- Non-Small Cell Lung Cancer, Stage IIIB or IV
- Keywords
- gemcitabine, pemetrexed, non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Southern Italy Cooperative Oncology GroupUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 Feb 2007 (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 aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG regimen) in terms of toxicity and QoL
Detailed description
Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to receive: (a)PG regimen: paclitaxel 120 mg/sqm followed by gemcitabine 1,000 mg/sqm i.v. on days 1 \& 8 q 3 weeks; (b)GA regimen: gemcitabine 1,250 mg/sqm i.v. on day 1 (plus folinic acid 350 μg daily orally and vitamin B12 1,000 μg i.m. q 9 weeks), pemetrexed (Alimta®) 500 mg/sqm i.v. on day 8 followed by gemcitabine 1,250 mg/sqm, q 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: gemcitabine plus pemetrexed, paclitaxel plus gemcitabineGemcitabine 1,250 mg/sqm days 1 and 8 + Alimta 500 mg/sqm day 8, every 3 weeks |
| B | Active comparator | Drug: gemcitabine plus pemetrexed, paclitaxel plus gemcitabinePaclitaxel 120 mg/sqm days 1 and 8 + Gemcitabine 1,000 mg/sqm days 1 and 8, every 3 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) NSCLC
- No previous adjuvant or palliative chemotherapy
- No previous radiotherapy
- Presence of at least one unidimensionally measurable lesion (Appendix 2)
- ECOG performance status of 0 or 1 (Appendix 3)
Key exclusion criteria (3 listed)
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
- Patients with clinically significant effusions.
- Any other malignancies within 5 years that could affect therapy evaluation
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 |
|---|---|---|
| gemcitabine plus pemetrexed, paclitaxel plus gemcitabinegemcitabine 1,250 mg/sqm days 1\&8 + pemetrexed 500 mg/sqm day 8 paclitaxel 120 mg/sqm + gemcitabine 1,000 mg/sqm days 1\&8 | Drug | A, B |
Primary outcome
Response rate of patients treated with the gemcitabine plus Alimta regimen
Time frame: after 3 cycles
2 secondary outcomes
Safety of patients treated with gemcitabine plus Alimta regimen
Time frame: at the end of treatment
Quality of life of patients treated with gemcitabine plus Alimta regimen
Time frame: after 3 cyces
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
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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.
Pasquale Comella, MD principal investigator
National Tumor Institute, Naples, Italy
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 gemcitabine plus pemetrexed, paclitaxel plus gemcitabine in people with Non-Small Cell Lung Cancer and Stage IIIB or IV, run by Southern Italy Cooperative Oncology Group at 1 site in Italy.
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 12 inclusion and 3 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 5 Feb 2009. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate of patients treated with the gemcitabine plus Alimta regimen (time frame: after 3 cycles). 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 5 Feb 2009.