Docetaxel Intermittent-Erlotinib (Tarceva®) In Metastatic Non Small Cell Lung Cancer (NSCLC)

NCT00783471 | Terminated Phase 2

• 1 other identifier: HE 2D/07
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 13

Brief Summary

To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer

Conditions

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Assessment every 6 weeks

Secondary Outcomes (2)

• To compare the Overall Survival (OS),the Objective Response Rate (ORR) and duration of response

  Assessment every 6 weeks while on treatment and every 3 months post completion of 8 cycles of treatment until progression

• Identify predictive signaling molecules of the EGFR pathway

  Assessment every 6 weeks while on treatment and every 3 months post completion of 8 cycles of treatment until progression

Study Arms (2)

1

EXPERIMENTAL

Erlotinib followed by Docetaxel

Drug: Erlotinib, Docetaxel

2

EXPERIMENTAL

Docetaxel followed by Erlotinib

Drug: Docetaxel, Erlotinib

Interventions

Erlotinib, Docetaxel DRUG

Drug: Erlotinib 150 mg po daily, days 1-12 Drug: Docetaxel 75 mg/m2 IV over 30 min on day 15 Treatment will be repeated every 21 days

1

Docetaxel, Erlotinib DRUG

Drug: Docetaxel 75 mg/m2 IV over 30 min on day 1 Drug: Erlotinib 150 mg po daily, days 4-15 Treatment will be repeated every 21 days

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic NSCLC will be enrolled.
• Patients must have not been previously treated with anticancer drugs for advanced disease.
• ECOG performance status of 0 - 1.
• Life expectancy of at least 12 weeks.
• Patients must be able to take oral medication.
• At least 4 weeks since any prior major surgery or extended-field radiotherapy. Patients who, in the opinion of the investigator, have fully recovered from limited surgery or have undergone limited-field radiotherapy within 2 weeks may also be considered eligible for the study
• Granulocyte count \> 1,500/mm3 and platelet count \> 100,000/mm3. Haemoglobin ³ 9.0g/dl.
• SGOT (AST) and SGPT (ALT) \< 2,5 x ULN in the absence of liver metastases or up to 5 x ULN in case of liver metastases
• Alkaline phosphatase (ALP) \< 2,5 x ULN. If alkaline phosphatase is \> 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be \< 1.5 x ULN. If alkaline phosphatase is ³ 2.5 x ULN in the presence of liver metastases, SGOT and SGPT must be \< 5 x ULN
• Serum creatinine \<= 1.5 ULN or creatinine clearance \> 60 ml/min.
• Normal serum calcium.
• For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting Tarceva/placebo treatment.
• Patients with reproductive potential must use effective contraception.
• Able to comply with study and follow-up procedures.
• Written (signed) Informed Consent to participate in the study.

You may not qualify if:

• Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzumab).
• Prior chemotherapy or therapy with systemic anti-neoplastic therapy (e.g., monoclonal antibody therapy) for advanced disease. Prior surgery and/or localised irradiation is permitted.
• Patients who have undergone complete tumour resection after responding to platinum based chemotherapy.
• Any unstable systemic disease (including active infections, significant cardiovascular disease, \[including myocardial infarction within the previous year\], any significant hepatic, renal or metabolic disease) metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medication(s) or that might affect the interpretation of the results or render the patient at high risk from treatment complications.
• Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
• Patients are excluded if they have symptomatic brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; patients with CNS metastases with evidence of stable disease (clinically stable imaging) and stable neurologic function are allowed to enter the study.
• Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids are excluded.
• Any inflammatory changes of the surface of the eye.
• Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
• Nursing and/or pregnant women.
• Hypersensitivity to erlotinib (Tarceva) or to docetaxel or to any of the excipients.

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (13)

Sotiria Hospital

Athens, 11526, Greece

Location

"Alexandra" Hospital

Athens, 11528, Greece

Location

"Attikon" University Hospital, 2nd Dept. of Internal Medicine, Propaedeutic, Oncology Section

Athens, 12461, Greece

Location

Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology

Athens, 14564, Greece

Location

Hygeia Hospital

Athens, 15123, Greece

Location

University General Hospital of Ioannina, Medical Oncology Dept

Ioannina, 45500, Greece

Location

Larissa University Hospital

Larissa, 41110, Greece

Location

Metropolitan Hospital, Second Dept of Medical Oncology

Piraeus, 18547, Greece

Location

Metropolitan Hospital, 1st Dept. of Medical Oncology

Pireaus, 18547, Greece

Location

Patras University Hospital, Dept. of Internal Medicine, Oncology Section

Rio, Patras, 26500, Greece

Location

Theagenio Cancer Hospital, 2nd Dept of Medical Oncology

Thessaloniki, 54007, Greece

Location

Theagenio Cancer Hospital, 3rd Dept. of Medical Oncology

Thessaloniki, 54007, Greece

Location

"Papageorgiou" Hospital

Thessaloniki, 56403, Greece

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride; Docetaxel

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Evangelos Briasoulis, MD

  University of Ioannina Hospital, Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 16, 2010

Record last verified: 2010-06

Locations

GR (13)