Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Condition(s) targeted: Carcinoma, Squamous Cell

Intervention: Docetaxel (Drug)

Phase: Phase 2

Status: No longer recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Barbara Steiner, Study Director, Affiliation: Sanofi-Aventis

Primary objective:

• To assess the response rate to induction therapy with docetaxel/CDDP.

Secondary objectives:

To assess

• Resectability after induction therapy

• Time to progression

• Overall survival

• Safety profile

• Quality of Life

Official title: Multicenter Phase II Study Evaluating Docetaxel and CDDP as Induction Regimen Prior to Surgery or Radiochemotherapy With Docetaxel, Followed by Adjuvant Docetaxel Therapy in Chemonaive Patients With NSCLC Stage II, IIIa and IIIb

Study design: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

To assess the response rate (ORR) after induction therapy with docetaxel in combination with CDDP in patients with NSCLC stage II, IIIa and IIIb

ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the WHO guidelines.

Secondary outcome:

To evaluate resectability after induction therapy, which will be determined by lung function according to national guidelines(Arbeitskreis Bronchuskarzinom

Funktionelle Operationskriterien,1998)and for patients who were primary unresectable by mediastinoscopy

To assess time to progression (TTP) for all patients, who received at least 2 cycles of induction chemotherapy

TTP is defined as time elapsed from the date of patient inclusion until recorded date of progression(local failure, distant metastasis)

To assess overall survival (OS) (median survival time and percentage of 1-year survival)

To characterize and quantitate toxic effects of the scheduled therapy

Safety profile and tolerability will be assessed by recording adverse events,clinically significant laboratory abnormalities,physical examination and vital signs

Toxicities will be evaluated according to the WHO Toxicity Criteria and adverse events which are not reported in WHO will be graded as mild, moderate,severe or life-threatening

All patients who received any of the scheduled therapy will be included in the overall toxicity analysis

To evaluate the effect of the scheduled therapy on quality of life (QoL)

QoL will be assessed by questionnaire.

Minimum age: 19 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Histology and staging of the disease

- Histologically or cytologically confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC

- Resectable or unresectable NSCLC stage II (T1-2 N1, T3 N0) or stage IIIa (T1-2 N2 or T3 N1-2) or stage IIIb (T1-3 N3 or T4 N0-3)

- Measurable disease (bidimensionally or unidimensionally according to WHO criteria)

2. General conditions

- Karnofsky Status > 70, if age > 70 years → PS > 70

- Adequate hematological function (Hb > 10 g/dl, ANC > 2. 0 x 109/L, platelets > 100 x 109/L)

- Adequate renal and hepatic functions: total bilirubin < 1 x upper normal limit (UNL), serum creatinine < 1 x UNL, in case of limit value the creatinine clearance should be > 60 ml/min, ASAT and ALAT < 2. 5 x UNL, alkaline phosphatase < 5 x UNL.

Exclusion Criteria:

1. Diagnosis

- Evidence of brain metastases or other distant metastasis equivalent to stage IV disease

- History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years

- Other serious concomitant illness or medical condition:

* Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia

* History of significant neurologic or psychiatric disorders, including dementia or seizure

* Active infection requiring i. v. Antibiotics

* Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy

- Hepatic function abnormality: ASAT and/or ALAT > 1. 5 x UNL associated with alkaline phosphatase > 2. 5 x UNL

- Current peripheral neuropathy WHO grade > 2

2. Prior or concurrent therapy

- Prior chemotherapy or immunotherapy for NSCLC, including neoadjuvant or adjuvant treatment

- Prior surgery or radiotherapy for NSCLC

- Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy

3. General conditions

- Pregnant or lactating patients

- Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements

The above information is not intended to contain all considerations relevant to a patient’s potential participation in a clinical trial.

Sanofi-Aventis, Vienna 6020, Austria

Starting date: March 2001
Last updated: June 22, 2007