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Phase II, Multicenter, Randomized, Open Label Study of a Sequential Treatment of Intermittent Erlotinib and Docetaxel Versus Erlotinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer After Failure of a Prior Chemotherapy Regimen


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

Phase II, Multicenter, Randomized, Open Label Study of a Sequential Treatment of Intermittent Erlotinib and Docetaxel Versus Erlotinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer After Failure of a Prior Chemotherapy Regimen


Inclusion Criteria:



- Written informed consent.

- Age >= 18 years.

- Histologically or cytologically documented inoperable, locally advanced (stage IIIb
with malignant pleural or pericardial effusion) or metastatic (Stage IV) NSCLC.

- Patients who have failed only one prior chemotherapy to treat the advanced disease
and candidates to receive a second line treatment.

- ECOG PS 0-2.

- Adequate hematological function: hemoglobin => 9 g/dl; neutrophils count => 1.5 x
10(9)/l; platelet count => 100 x 10(9)/l.

- Adequate liver function: Bilirubin <= 1,5 x ULN; AST and ALT <= x 3 ULN when no
hepatic metastases or <=5 x ULN if hepatic metastases; Alkaline phosphatase <=5 x UNL
except that there is hepatic metastases.

- Adequate renal function: Calculated creatinine clearance => 40 mL/min (Cockroft y
Gault) or serum creatinine <= 1.5 x ULN .

- Patient able to meet the requirements of the study and accessible for correct
follow-up.

- Oral swallowing capability.

Exclusion Criteria:

- Previous treated with more than one chemotherapeutic treatment for NSCLC

- Concomitant treatment with another drug under investigation.

- Pregnancy or lactation. Fertile women must provide a negative result of pregnancy
test (in serum or urine) within 7 days prior to study treatment start. In addition,
they must use an effective method of contraception (oral contraceptives, intrauterine
device, barrier methods of contraception, together with spermicidal jelly or surgical
sterilization) during the study.

- Evidence of other disease, metabolic or neurological dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates use of an investigational drug or patient
at high risk from treatment complications.

- Contraindication for the use of erlotinib or docetaxel.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients without disease progression after 6 months of treatment.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Oscar Juan, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Arnau de Vilanova de Valencia

Authority:

Spain: Spanish Agency of Medicines

Study ID:

ML25033

NCT ID:

NCT00908336

Start Date:

March 2009

Completion Date:

December 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Adenocarcinoma
  • Carcinoma, Non-Small Cell
  • Lung Neoplasms
  • Docetaxel
  • Erlotinib
  • Chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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