Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Sponsor:
Information provided by (Responsible Party):
Krankenhaus Nordwest
ClinicalTrials.gov Identifier:
NCT01222312
First received: April 12, 2010
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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

  • quality of life [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • progression free survival PFS [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
  • overall survival OS [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
  • time to treatment failure TTF [ Time Frame: every two weeks ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222312

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

No publications provided

Responsible Party: Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT01222312     History of Changes
Other Study ID Numbers: S417
Study First Received: April 12, 2010
Last Updated: November 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Docetaxel
Oxaliplatin
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 23, 2014