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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01222312
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : November 29, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Cisplatin Drug: Oxaliplatin Drug: Docetaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

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 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

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

Secondary Outcome Measures :
  1. 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01222312

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

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Responsible Party: Krankenhaus Nordwest Identifier: NCT01222312     History of Changes
Other Study ID Numbers: S417
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: November 29, 2011
Last Verified: November 2011
Keywords provided by Krankenhaus Nordwest:
advanced NSCLC
locally advanced or metastatic non small cell lung cancer (stage IIIB-IV)
Additional relevant MeSH terms:
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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