Study for Therapy of Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) With Cisplatin / Docetaxel or Oxaliplatin / Docetaxel

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Cisplatin; Drug: Oxaliplatin; Drug: Docetaxel

• Registration Number: NCT01222312
• Lead Sponsor: Krankenhaus Nordwest

Brief Summary

The study compares two combinations of chemotherapy in patients with advanced or metastatic NSCLC: 50% of the patients are treated with cisplatin and docetaxel, the other 50% with oxaliplatin and docetaxel. cisplatin is today the standard therapy, but the toxicity profile is often not tolerable. Especially in elderly patients or patients with comorbidities, oxaliplatin based chemotherapy may have lower toxicities but comparable or even better response rates.

Detailed Description

Cispaltin based chemotherapies are standard for palliative first-line therapy in patients with advanced or metastatic NSCLC. Due to contraindications to cisplatin, this substance can not be used in a high number of patients. Especially in elderly patients, patients with comorbidities and patients with reduced general condition, cisplatin is a therapy which often induces intolerable toxicities. Thus, therapy often has to be interrupted or finished prematurely. Due to its favorable toxicity profile, oxaliplatin can be used also for the treatment of elderly patients and patients with comorbidities. Based on toxicity data from a phase II study of our group in patients with gastric cancer, the dosage for oxaliplatin/docetaxel was adopted for this actual study. In previous phase II trials, response rates of oxaliplatin based combination chemotherapies were comparable to those with cisplatin in patients with metastatic NSCLC.

In this study we will analyse, if a oxaliplatin based combination chemotherapy has a more tolerable toxicity profile and comparable or even better response rate in comparison to a cisplatin based chemotherapy. 44 patients in each arm will either be treated with a maximum of 6 cycles cisplatin/docetaxel or a maximum of 8 cycles oxaliplatin/docetaxel.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-18
• Primary Completion: 2011-10
• Status Verified: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-28
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• histologically or cytologically confirmed NSCLC stage IIIB or IV.
• no previous chemotherapy in metastatic state
• male and female patients aged > 18 years
• ECOG ≤ 2
• Leukocytes > 3.000/µl
• Thrombocytes > 100.000/µl
• Serum creatinine ≤ 1.25x normal value, or Creatinine Clearance > 45 ml/min
• previous radiation < 25% bone marrow region allowed. Previous radiation of whole pelvis not allowed
• parallel radiation allowed, if target lesion outside of radiation field
• written informed consent
• life expectancy > 3 months

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Exclusion Criteria

• hypersensibility against Cisplatin, Oxaliplatin or Docetaxel
• Neoadjuvant or adjuvant chemotherapy within the last 6 months
• radiation within the last 28 days
• severe systemic comorbidities
• Cardiomyopathy or cardiac insufficiency stage II-IV according to NYHA
• malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
• brain metastases
• severe non-surgical comorbidities or acute infection
• peripheral polyneuropathy > NCI grade II
• severe liver dysfunction AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)
• participation in parallel trial
• pregnancy and lactation
• reduced hearing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B oxaliplatin	Docetaxel	Oxaliplatin 85 mg/m², d1 Docetaxel 50mg/m2, d1 every 2 weeks (d15) max. 8 cycles
Arm A cisplatin	Cisplatin	Cisplatin 75 mg/m2, d1 Docetaxel 75 mg/m2, d1 every 3 weeks (d22) max. 6 cycles
Arm A cisplatin	Docetaxel	Cisplatin 75 mg/m2, d1 Docetaxel 75 mg/m2, d1 every 3 weeks (d22) max. 6 cycles
Arm B oxaliplatin	Oxaliplatin	Oxaliplatin 85 mg/m², d1 Docetaxel 50mg/m2, d1 every 2 weeks (d15) max. 8 cycles

Primary Outcome Measures

Name	Time	Method
response rate	staging every 2 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	every two weeks	comparison of adverse events (all grades, grade 3/4) in the Cisplatin vs Oxaliplatin arm
quality of life	every 8 weeks
progression free survival PFS	every 2 months
overall survival OS	6 months follow-up
time to treatment failure TTF	every two weeks

Trial Locations

Locations (1)

Krankenhaus Nordwest; 🇩🇪 Frankfurt/Main, Germany