Docetaxel in Non Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00432315

Purpose

Primary objective:

Secondary objectives:

To assess

Condition	Intervention	Phase
Carcinoma, Squamous Cell	Drug: Docetaxel + CDDP Drug: docetaxel + CDDP	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

Drug Information available for: Docetaxel

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To assess the response rate to induction therapy with docetaxel in combination with CDDP [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Resectability after induction therapy [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ] [ Designated as safety issue: No ]
Safety profile [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	May 2001
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Resectable NSCLC	Drug: Docetaxel + CDDP 3 cycles chemotherapy : docetaxel + CDDP Surgery (if no histologically proven R0-resection could be achieved,additional adjuvant radiotherapy should be considered) 3 cycles adjuvant chemotherapy docetaxel
2: Experimental Unresectable NSCSC	Drug: docetaxel + CDDP 3 cycles chemotherapy: docetaxel + CDDP Radiochemotherapy 3 cycles adjuvant chemotherapy docetaxel

Eligibility

Criteria

Inclusion Criteria:

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)
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:

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
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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432315

Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Alexandra Edlmayer, Dr.

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	TAX_AT1_203
Study First Received:	February 6, 2007
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00432315 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety

Study placed in the following topic categories:

Docetaxel
Lung Neoplasms
Adjuvants, Immunologic
Non-small Cell Lung Cancer
Neoplasms, Squamous Cell

Carcinoma, Squamous Cell
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Pharmacologic Actions
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 02, 2009