Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00271323
• Date of registration: 29/12/2005
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients
• Scientific title: A Two Arm Phase II Study Assessing Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-multiple cN2 or IIIB)
• Date of first enrolment: May 2005
• Target sample size: 14
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00271323
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: M COUDERC, Dr
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Informed consent form obtained, signed and dated before specific protocol procedures.

2. Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell
carcinoma, large cell carcinoma or a combination of these)

3. Patients must have a loco regionally advanced unresectable NSCLC;

- Stage IIIA with clinical multiple N2 nodes (preferably with histological or
cytological confirmation).

- Patients with peripheral tumours of the lower lobe with contralateral upper
mediastinal nodes at station N2 are excluded·

- Stage IIIB T4 or N3.

- In the T4 category, patients with pleural or pericardial effusion and
multiple nodules in the same lobe are excluded.

- Patients with T4 disease secondary to extensive and massive involvement of
the great vessels are excluded.Patients should be excluded when the
expected risk of pulmonary toxicity is likely to be high, e.g. V20 in
excess of 35%.

4. Males or females aged between 18 and 75 years.

5. Life expectancy of at least 12 weeks.

6. WHO performance status 0 or 1.

7. Weight loss <=10% within the last 3 months.

8. Laboratory requirements at entry (within 7 days before randomization):

- Blood cell counts:

- Absolute neutrophils >= 2.0 x 10^9/L

- Platelets >= 100 x 10^9/L

- Hemoglobin >= 10 g/dl

- Renal function:

- Serum creatinine <=1 x the upper limit of normal (UNL). In case of
borderline value of serum creatinine, the 24h creatinine clearance should
be >= 60 mL/min.

- Hepatic function:

- Serum bilirubin <= 1 x UNL

- ASAT and ALAT <= 2.5 x UNL

- Alkaline phosphatase <= 5 x UNL Patients with ASAT and/or ALAT > 1.5 x UNL
associated with alkaline phosphatase> 2.5 x UNL are not eligible for the
study.

9. Lung function tests at entry:

- FEV1: >= 50 % x Normal value

- DLCO: >= 50 % x Normal value

10. Adequate cardiac function.

11. Patient with either measurable and/or non-measurable lesion (according to RECIST
criteria).

Exclusion Criteria:

1. Diagnosis of small cell lung cancer.

2. Pregnant or lactating women.

3. Patients (male or female) with reproductive potential not implementing adequate
contraceptive measures.

4. Prior systemic chemotherapy, immunotherapy, or biological therapy including
neoadjuvant or adjuvant treatment for NSCLC.

5. Prior surgery for NSCLC, if less than 5 years from study.

6. Prior radiotherapy for NSCLC.

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

8. Symptomatic peripheral neuropathy Grade >= 2 except if due to trauma.

9. Other serious concomitant illness or medical conditions:

- Congestive heart failure or angina pectoris except if it is medically
controlled. Previous history of myocardial infarction within 1 year from study
entry, uncontrolled hypertension or arrhythmias.

- History of significant neurological or psychiatric disorders including dementia
or seizures.

- Active infection requiring IV antibiotics.

- Active ulcer, unstable diabetes mellitus or other contra-indication to
corticosteroid therapy.

- Superior vena cava syndrome contra-indicating hydration.

- Preexisting pericardial effusion.

- Preexisting symptomatic pleural effusion.

10. Significant gastrointestinal abnormalities, including requirement for intravenous
nutrition, active peptic ulcer disease, prior surgical procedures affecting
absorption.

11. Distant metastasis.

12. Concurrent treatment with any other experimental anti-cancer drugs.

13. Concomitant or within 4-week period administration of any other experimental drug
under investigation.

14. Significant ophthalmologic abnormalities.

15. Moderate to severe dermatitis.

16. Hypersensitivity to docetaxel, cisplatin, or any of its excipients.

17. Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.

18. Mental condition rendering the patient unable to understand the nature, scope, and
possible consequences of the study.

19. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to
return for follow-up visits, and not likely to complete the study.

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Non-Small-Cell Lung Carcinoma

Intervention(s)

Radiation: radiotherapy

Drug: docetaxel and cisplatin

Primary Outcome(s)

time to progression [Time Frame: from the date of start treatment until progression]

duration of response [Time Frame: only on responders]

overall response rate [Time Frame: in population of patients eligible and evaluable for response]

Secondary ID(s)

EudraCT #: 2005-001276-12

XRP6976B_2507

Source(s) of Monetary Support

Please refer to primary and secondary sponsors