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

Non Small Cell Lung Cancer Clinical Trial

— Taxelox  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222312
• Other study ID #: S417
• Status: Completed
• Phase: Phase 2
• First received: April 12, 2010
• Last updated: November 28, 2011
• Start date: August 2008
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Krankenhaus Nordwest
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Cisplatin
75 mg/m2, d1 every 3 weeks
• Oxaliplatin
85 mg/m², d1 every 2 weeks
• Docetaxel
75 mg/m2, d1 every 3 weeks
• Docetaxel
50mg/m2, d1 every 2 weeks

Locations

Country	Name	City	State
Germany	Krankenhaus Nordwest	Frankfurt/Main

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		staging every 2 months	No
Secondary	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	Yes
Secondary	quality of life		every 8 weeks	No
Secondary	progression free survival PFS		every 2 months	No
Secondary	overall survival OS		6 months follow-up	No
Secondary	time to treatment failure TTF		every two weeks	No