First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia (IPASS)
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| ClinicalTrials.gov Identifier: NCT00322452 |
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Recruitment Status :
Completed
First Posted : May 8, 2006
Results First Posted : May 17, 2010
Last Update Posted : November 7, 2013
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small Cell Lung Cancer | Drug: Gefitinib Drug: Carboplatin Drug: Paclitaxel | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1329 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia |
| Study Start Date : | March 2006 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | June 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
gefitinib
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Drug: Gefitinib
oral tablet
Other Names:
|
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Active Comparator: 2
Carboplatin/Paclitaxel
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Drug: Carboplatin
IV Drug: Paclitaxel IV |
Primary Outcome Measures :
- Median Progression Free Survival (PFS) in Months [ Time Frame: Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008). ]PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.
Secondary Outcome Measures :
- Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010) [ Time Frame: Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks. ]Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. Median Overall Survival in months is presented here.
- Objective Tumour Response Rate According to RECIST [ Time Frame: Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008). ]Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
- Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]Number of patients with a neutropenia event, identified from the lab data as a worsening in absolute neutrophil count from baseline to a CTC grade 3 or above which Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
- Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]Number of patients with a thromboctyopenia event, identified from the lab data as a worsening in platelet count from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
- Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]Number of patients with a leukopenia event, identified from the lab data as a worsening in white blood cell count from baseline to a CTC grade 3 or above. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
- Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]Number of patients with an anaemia event, identified from the lab data as a worsening in haemoglobin from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
- Neurotoxicity [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]Number of patients with a neurotoxicity event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
- Rashes/Acnes [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]Number of patients with a rashes/acnes event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
- Diarrhoea [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]Number of patients with a diarrhoea event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
- Nausea [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]Number of patients with a nausea event. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
- Vomiting [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]Number of patients with a vomiting event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
- Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]Number of patients with an elevated liver transaminase event, identified from the lab data as a worsening in ALT or AST from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
- Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire [ Time Frame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. ]Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in FACT-L score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit
- Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire [ Time Frame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. ]Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in TOI score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit
- Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire [ Time Frame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. ]Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in LCS score (from baseline) of 2 or more, and there were no intervening visits showing a decrease from baseline of 2 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic) NSCLC with adenocarcinoma histology.
- Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of study treatment and 10 pack-years or fewer)
Exclusion Criteria:
- Had prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.
- Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322452
Locations
Show 56 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Alison Armour, MD | AstraZeneca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00322452 |
| Other Study ID Numbers: |
D791AC00007 Iressa Pan Asian Study (IPASS) |
| First Posted: | May 8, 2006 Key Record Dates |
| Results First Posted: | May 17, 2010 |
| Last Update Posted: | November 7, 2013 |
| Last Verified: | October 2013 |
Keywords provided by AstraZeneca:
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NSCLC Gefitinib |
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Paclitaxel |
Carboplatin Gefitinib Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors |