search
Back to results

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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cisplatin
Oxaliplatin
Docetaxel
Docetaxel
Sponsored by
Krankenhaus Nordwest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring advanced NSCLC, oxaliplatin, cisplatin, docetaxel, locally advanced or metastatic non small cell lung cancer (stage IIIB-IV)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Krankenhaus Nordwest

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A cisplatin

Arm B oxaliplatin

Arm Description

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

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

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

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
quality of life
progression free survival PFS
overall survival OS
time to treatment failure TTF

Full Information

First Posted
April 12, 2010
Last Updated
November 28, 2011
Sponsor
Krankenhaus Nordwest
search

1. Study Identification

Unique Protocol Identification Number
NCT01222312
Brief Title
Study for Therapy of Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) With Cisplatin / Docetaxel or Oxaliplatin / Docetaxel
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krankenhaus Nordwest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
advanced NSCLC, oxaliplatin, cisplatin, docetaxel, locally advanced or metastatic non small cell lung cancer (stage IIIB-IV)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A cisplatin
Arm Type
Active Comparator
Arm Description
Cisplatin 75 mg/m2, d1 Docetaxel 75 mg/m2, d1 every 3 weeks (d22) max. 6 cycles
Arm Title
Arm B oxaliplatin
Arm Type
Experimental
Arm Description
Oxaliplatin 85 mg/m², d1 Docetaxel 50mg/m2, d1 every 2 weeks (d15) max. 8 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m2, d1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
85 mg/m², d1 every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
75 mg/m2, d1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
50mg/m2, d1 every 2 weeks
Primary Outcome Measure Information:
Title
response rate
Time Frame
staging every 2 months
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
comparison of adverse events (all grades, grade 3/4) in the Cisplatin vs Oxaliplatin arm
Time Frame
every two weeks
Title
quality of life
Time Frame
every 8 weeks
Title
progression free survival PFS
Time Frame
every 2 months
Title
overall survival OS
Time Frame
6 months follow-up
Title
time to treatment failure TTF
Time Frame
every two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elke Jäger, Prof. Dr.
Organizational Affiliation
Krankenhaus Nordwest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus Nordwest
City
Frankfurt/Main
ZIP/Postal Code
60488
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs