Randomized Gefitinib Trial (RANGE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fondazione Humanitas per la Ricerca
ClinicalTrials.gov Identifier:
NCT00807066
First received: December 10, 2008
Last updated: April 20, 2012
Last verified: October 2010
  Purpose

Patients with locally advanced (IIIB with effusion) or metastatic non-small cell lung cancer (NSCLC), EGFR FISH positive, candidate for a first-line platinum-based chemotherapy will be considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all eligible patients will be randomized to receive standard chemotherapy (control arm) or gefitinib (250 mg daily dose-experimental arm). Before, and in every case, no more than 4 weeks before study entry, all eligible patients will receive a complete disease staging, including thoracic and abdominal CT-scan, and blood sampling. Bronchoscopy will be done if not previously performed. Bone scan and brain CT-scan will be performed only if clinically indicated. Disease assessment will be performed every 6 weeks (every 2 cycles) for the first 6 cycles, and thereafter every 3 months, with a confirmatory evaluation in all patients with response or disease stabilization no less than 4 weeks after the response assessment, according to RECIST Criteria. A complete disease staging, including the above mentioned procedures, will be performed in case of progressive disease, and, in every cases, when patient withdrawals the trial. Following completion of protocol therapy, patients will be followed every 3 months.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Gefitinib
Drug: Platinum
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric Randomized Phase III Study Comparing Gefitinib Versus Platinum-Based Chemotherapy In EGFR Fish Positive NSCLC Patients (Range)

Resource links provided by NLM:


Further study details as provided by Fondazione Humanitas per la Ricerca:

Primary Outcome Measures:
  • Quality of life (FACT-L Total Score) [ Time Frame: EVERY 3 WEEKS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression (TTP), Objective Response Rate (ORR), overall survival (OS), and tolerability. [ Time Frame: every two months ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Gefitinib
Drug: Gefitinib
Gefitinib 250 mg/day
Active Comparator: B
Platinum based chemotherapy
Drug: Platinum
Platinum based chemotherapy with cycles every 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with locally advanced or metastatic NSCLC, EGFR FISH positive, candidate for a first-line platinum-based chemotherapy
  • Histologically confirmed diagnosis of non-squamous NSCLC. Availability of tumor tissue for EGFR FISH analysis is mandatory
  • Stage IIIB (with effusion) or stage IV or disease relapsed after surgery or radiotherapy and in any case not suitable for radiotherapy or surgery with curative intent
  • EGFR FISH positive
  • Presence of at least one measurable/evaluable not previously irradiated lesion according to RECIST criteria. Previously irradiated lesion(s) are allowed only if progressing
  • ECOG performance Status 0-2
  • Patient untreated with chemotherapy or EGFR targeting agents. Adjuvant chemotherapy is allowed if disease relapsed after at least 12 months after therapy completion.
  • Patient candidate to standard platinum-based chemotherapy
  • Patient compliance to trial procedures
  • Patients must be willing to complete the FACT-L questionnaire
  • Age ≥ 18 years

Exclusion Criteria:

  • EGFR FISH negative tumor
  • Squamous-cell carcinoma, presence of neuroendocrine features or small cell carcinoma histology
  • Impossibility to ascertain EGFR FISH status
  • Concomitant radiotherapy
  • Less than 30 days since completion of prior wide field chest radiotherapy or persistence of any radiotherapy related toxicity.
  • Symptomatic brain metastases or newly diagnosed central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease and are not receiving steroid therapy.
  • Known severe hypersensitivity to gefitinib or any of the excipients of this product
  • Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
  • All disease sites previously included in radiotherapy fields. If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.
  • Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uterine and squamous cell carcinoma of the skin
  • Any previous chemotherapy or EGFR targeting agents
  • Pregnancy or lactating. Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
  • Males must be willing to practice acceptable methods of birth control whilst taking study medication to prevent pregnancy of a partner.
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • Concomitant use of phenytoin, carbamazepine, rifampicin, rifabutin, barbiturates or St John's Wort (Hypercium).
  • Serum bilirubin greater than 3 times the upper limit of reference range (ULRR
  • Alanine amino transferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases.
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  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: NCT00807066

Locations
Italy
Fondazione Humanitas per la Ricerca
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Fondazione Humanitas per la Ricerca
Investigators
Principal Investigator: Armando Santoro, MD Fondazione Humanitas per la Ricerca
  More Information

No publications provided

Responsible Party: Fondazione Humanitas per la Ricerca
ClinicalTrials.gov Identifier: NCT00807066     History of Changes
Other Study ID Numbers: ONC-2008-001
Study First Received: December 10, 2008
Last Updated: April 20, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Fondazione Humanitas per la Ricerca:
QUALITY OF LIFE

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
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014