A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01204697
First received: September 16, 2010
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This randomized parallel group study will assess the efficacy and safety of erlotinib [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: erlotinib [Tarceva] Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Trial of Erlotinib or Intermittent Dosing of Erlotinib and Docetaxel in Male Former-smokers With Locally Advanced or Metastatic Squamous NSCLC in Second-line Setting After Failure on Chemotherapy |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Rate of progression-free survival (tumour assessments according to RECIST criteria) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
- Objective response rate (ORR), tumour assessments according to RECIST criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Duration of response, tumour assessments according to RECIST criteria [ Time Frame: from response to progressive disease ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: through study (up to 3 years) ] [ Designated as safety issue: No ]
| Enrollment: | 74 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: erlotinib [Tarceva]
150 mg/day orally as monotherapy
|
| Experimental: B |
Drug: erlotinib [Tarceva]
150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter
Drug: docetaxel
75 mg/m2 intravenously every 3 weeks for 4 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- male patients, >/=18 years of age
- former smoker (smoked >/= 100 cigarettes in his lifetime and quit >12 months before enrollment)
- locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small cell lung cancer
- prior platinum-based therapy for advanced NSCLC
- ECOG performance status 0-1
Exclusion Criteria:
- uncontrolled symptomatic central nervous system (CNS) metastases
- prior therapy against epidermal growth factor receptor (EGFR)
- >1 prior chemotherapy for advanced/metatstatic NSCLC
- radiotherapy <28 days prior to enrollment
- history of melanoma at any time, or another malignancy in the last 5 years except for carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or surgically cured malignant neoplasias with a disease-free interval of >5 years
- not fully treated eye inflammation or infection, or predisposing conditions
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204697
Locations
| Italy | |
| Avellino, Italy, 83100 | |
| Aviano (pn), Italy, 33081 | |
| Cremona, Italy, 26100 | |
| Lecce, Italy, 73100 | |
| Lido Di Camaiore, Italy, 55041 | |
| Macerata, Italy, 62100 | |
| Milano, Italy, 20142 | |
| Monza, Italy, 20052 | |
| Napoli, Italy, 80131 | |
| Parma, Italy, 43100 | |
| Pavia, Italy, 27100 | |
| Pisa, Italy, 56124 | |
| Pontedera, Italy, 56025 | |
| Roma, Italy, 00168 | |
| Roma, Italy, 00151 | |
| Roma, Italy, 00157 | |
| San Giovanni Rotondo, Italy, 71013 | |
| Sondalo, Italy, 23039 | |
| Treviso, Italy, 31100 | |
| Vicenza, Italy, 36100 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01204697 History of Changes |
| Other Study ID Numbers: | ML21869 |
| Study First Received: | September 16, 2010 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Docetaxel Erlotinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013