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

NCT01222312 | Completed Phase 2 DMC

• 1 other identifier: S417
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

advanced NSCLC; oxaliplatin; cisplatin; docetaxel; locally advanced or metastatic non small cell lung cancer (stage IIIB-IV)

Outcome Measures

Primary Outcomes (1)

• response rate

  staging every 2 months

Secondary Outcomes (5)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  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

Study Arms (2)

Arm A cisplatin

ACTIVE COMPARATOR

Cisplatin 75 mg/m2, d1 Docetaxel 75 mg/m2, d1 every 3 weeks (d22) max. 6 cycles

Drug: Cisplatin; Drug: Docetaxel

Arm B oxaliplatin

EXPERIMENTAL

Oxaliplatin 85 mg/m², d1 Docetaxel 50mg/m2, d1 every 2 weeks (d15) max. 8 cycles

Drug: Oxaliplatin; Drug: Docetaxel

Interventions

Cisplatin DRUG

75 mg/m2, d1 every 3 weeks

Arm A cisplatin

Oxaliplatin DRUG

85 mg/m², d1 every 2 weeks

Also known as: Eloxatin

Arm B oxaliplatin

Docetaxel DRUG

75 mg/m2, d1 every 3 weeks

Also known as: Taxotere

Arm A cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Krankenhaus Nordwest: lead

Study Sites (1)

Krankenhaus Nordwest

Frankfurt am Main, 60488, Germany

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Oxaliplatin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Elke Jäger, Prof. Dr.

  Krankenhaus Nordwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: October 18, 2010
• Study Start: August 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 29, 2011

Record last verified: 2011-11

Locations

DE (1)