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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01204697
First received: September 16, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This randomized parallel group study will assess the efficacy and safety of erlo tinib [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second

-line setting in former-smoker male patients with advanced or metastatic squamou s non-small cell lung cancer. Patients will be randomized to receive either Tarc eva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intrav enously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) fo llowed by Tarceva monotherapy. Anticipated time on study treatment is until dise ase 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: June 2014
Estimated Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204697

Locations
Italy
Avellino, Campania, Italy, 83100
Napoli, Campania, Italy, 80131
Parma, Emilia-Romagna, Italy, 43100
Aviano (PN), Friuli-Venezia Giulia, Italy, 33081
Roma, Lazio, Italy, 00152
Roma, Lazio, Italy, 00157
Roma, Lazio, Italy, 00168
Cremona, Lombardia, Italy, 26100
Milano, Lombardia, Italy, 20142
Monza, Lombardia, Italy, 20052
Pavia, Lombardia, Italy, 27100
Sondalo, Lombardia, Italy, 23039
Macerata, Marche, Italy, 62100
Lecce, Puglia, Italy, 73100
San Giovanni Rotondo, Puglia, Italy, 71013
Lido Di Camaiore, Toscana, Italy, 55043
Pisa, Toscana, Italy, 56124
Pontedera, Toscana, Italy, 56025
Treviso, Veneto, Italy, 31100
Vicenza, Veneto, 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: June 23, 2014
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 July 24, 2014