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

Multicenter Randomized Phase II Study for the Therapy of Locally Advanced or Metastatic NSCLC (Stage IIIB/IV) With Cisplatin/Docetaxel or Oxaliplatin/Docetaxel

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Cisplatin; Drug: Docetaxel; Drug: Docetaxel; Drug: Oxaliplatin

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Frankfurt/Main, Germany, 60488
    • Krankenhaus Nordwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A cisplatin; Cisplatin 75 mg/m2, d1 Docetaxel 75 mg/m2, d1 every 3 weeks (d22) max. 6 cycles	Drug: Cisplatin; 75 mg/m2, d1 every 3 weeks; Drug: Docetaxel; 75 mg/m2, d1 every 3 weeks; Other Names: Taxotere; Drug: Docetaxel; 50mg/m2, d1 every 2 weeks; Other Names: Taxotere
Experimental: Arm B oxaliplatin; Oxaliplatin 85 mg/m², d1 Docetaxel 50mg/m2, d1 every 2 weeks (d15) max. 8 cycles	Drug: Docetaxel; 75 mg/m2, d1 every 3 weeks; Other Names: Taxotere; Drug: Docetaxel; 50mg/m2, d1 every 2 weeks; Other Names: Taxotere; Drug: Oxaliplatin; 85 mg/m², d1 every 2 weeks; Other Names: Eloxatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
response rate	staging every 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	comparison of adverse events (all grades, grade 3/4) in the Cisplatin vs Oxaliplatin arm	every two weeks
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

Collaborators and Investigators

• Sponsor: Krankenhaus Nordwest
• Investigators: Principal Investigator: Elke Jäger, Prof. Dr., Krankenhaus Nordwest

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): November 29, 2011
• Last Update Submitted That Met QC Criteria: November 28, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: cisplatin; oxaliplatin; docetaxel; advanced NSCLC; locally advanced or metastatic non small cell lung cancer (stage IIIB-IV)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Oxaliplatin
• Other Study ID Numbers: S417