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

This study has been completed.
Information provided by (Responsible Party):
Krankenhaus Nordwest Identifier:
First received: April 12, 2010
Last updated: November 28, 2011
Last verified: November 2011
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.

Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Cisplatin
Drug: Oxaliplatin
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Phase II Study for the Therapy of Locally Advanced or Metastatic NSCLC (Stage IIIB/IV) With Cisplatin/Docetaxel or Oxaliplatin/Docetaxel

Resource links provided by NLM:

Further study details as provided by Krankenhaus Nordwest:

Primary Outcome Measures:
  • response rate [ Time Frame: staging every 2 months ]

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

  • quality of life [ Time Frame: every 8 weeks ]
  • progression free survival PFS [ Time Frame: every 2 months ]
  • overall survival OS [ Time Frame: 6 months follow-up ]
  • time to treatment failure TTF [ Time Frame: every two weeks ]

Enrollment: 88
Study Start Date: August 2008
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Taxotere
Experimental: Arm B oxaliplatin
Oxaliplatin 85 mg/m², d1 Docetaxel 50mg/m2, d1 every 2 weeks (d15) max. 8 cycles
Drug: Oxaliplatin
85 mg/m², d1 every 2 weeks
Other Name: Eloxatin
Drug: Docetaxel
50mg/m2, d1 every 2 weeks
Other Name: Taxotere

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01222312

Krankenhaus Nordwest
Frankfurt/Main, Germany, 60488
Sponsors and Collaborators
Krankenhaus Nordwest
Principal Investigator: Elke Jäger, Prof. Dr. Krankenhaus Nordwest
  More Information

Responsible Party: Krankenhaus Nordwest Identifier: NCT01222312     History of Changes
Other Study ID Numbers: S417
Study First Received: April 12, 2010
Last Updated: November 28, 2011

Keywords provided by Krankenhaus Nordwest:
advanced NSCLC
locally advanced or metastatic non small cell lung cancer (stage IIIB-IV)

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 21, 2017