Mono Versus Polichemotherapy in Non Small Cell Lung Cancer (NSCLC) Elderly Patients
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Purpose
Between 10% and 25% of newly diagnosed stage IIIB/stage IV patients currently receive single agent chemotherapy regimens. A significant proportion of these patients will be elderly (70 years of age) and many oncologists would consider intravenous vinorelbine or gemcitabine to be the standard of care in this patient population. It has been demonstrated that single agent vinorelbine offers therapeutic advantages to selected NSCLC patients over best supportive care alone.
Carboplatin plus Alimta have an acceptable toxicity profile and few clinical problems so it could be acceptable its use in elderly patients.
A randomised study is being performed therefore to assess whether progression free survival, the primary efficacy endpoint for this study, achieved with Carboplatin plus Alimta is superior than achieved with gemcitabine, one of the current standards of care in elderly patients with advanced NSCLC.
| Condition | Intervention | Phase |
|---|---|---|
|
NSCLC |
Drug: Pemetrexed/Carboplatin Drug: Gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Progression Free Survival Comparing Gemcitabine (1000 mg/m2 Infusion) Versus Carboplatin (AUC5 Infusion) Plus Alimta (500 mg/m2 Infusion) as First-line Chemotherapy in Elderly Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC) |
- Evaluate Progression Free Survival of Carboplatin plus Alimta vs gemcitabine in chemonaive, elderly stage IIIB-IV NSCLC patients. [ Time Frame: Efficacy after the inclusion of the last patient ] [ Designated as safety issue: Yes ]
- Overall Survival Quality of life [ Time Frame: After the follow up period ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 108 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pemetrexed/Carboplatin
Pemetrexed (500 mg/m2 infusion) plus Carboplatin (AUC5 infusion)
|
Drug: Pemetrexed/Carboplatin
Patients will receive Pemetrexed intravenous infusion (i.v.) via infusion pump or gravity drip, at a dose of 500 mg/m2 (over a target of 10 minutes). Pemetrexed should be administered every 21 days on the same day. Patients will receive carboplatin intravenous continuous infusion (i.v.) over 30 minutes via infusion pump or gravity drip, at a dose of AUC5. Carboplatin should be administered every 21 days on the same day. |
|
Active Comparator: Gemcitabine
Gemcitabine 1250 mg/mq
|
Drug: Gemcitabine
Patients will receive gemcitabine 1250 mg/m2 as a 30 minutes intravenous infusion on days 1 and 8 and of a 21-day cycle.Patients may continue to receive gemcitabine for up to a maximum of 6 cycles.
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- NSCLC, locally advanced (stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
- Female or male patients aged 70 years and over
- Measurable disease according to RECIST criteria, with at least one measurable lesion
- No prior chemotherapy, biological or immunological therapy
- Adeguate hepatic, renal and bone marrow function
- ECOG Performance Status ≤ 2
- Life expectancy of at least 12 weeks
Exclusion Criteria:
- Newly diagnosed CNS metastases that have not been treated with surgery or radiation
- Less than 4 weeks since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
- Any other experimental or anti-cancer therapy within 30 days before study drug administration
- Concurrent treatment with any other experimental or anti-cancer therapy
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00754364
| Italy | |
| Istituto Clinco Humanitas | |
| Rozzano, Milan, Italy, 20089 | |
| Principal Investigator: | Armando Santoro, MD | Istituto Clinico Humanitas |
More Information
No publications provided
| Responsible Party: | Armando Santoro, MD, MD, Istituto Clinico Humanitas |
| ClinicalTrials.gov Identifier: | NCT00754364 History of Changes |
| Other Study ID Numbers: | ONC-2007-003 |
| Study First Received: | September 17, 2008 |
| Last Updated: | January 28, 2014 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Carboplatin Gemcitabine Pemetrexed Anti-Infective Agents |
Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antiviral Agents Enzyme Inhibitors Folic Acid Antagonists Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015