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Non Small Cell Lung CancerPhase 2TaxeloxNCT01222312

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

A Phase 2 study testing Cisplatin, Oxaliplatin and Docetaxel in people with Non Small Cell Lung Cancer, run by Krankenhaus Nordwest at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Cisplatin, Oxaliplatin and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteGermany
Study dates
Aug 2008to Nov 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

Other trials in Germany

About this study

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

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.

Read the 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.

Keywords
advanced NSCLC, oxaliplatin, cisplatin, docetaxel, locally advanced or metastatic non small cell lung cancer (stage IIIB-IV)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    75 mg/m2, d1 every 3 weeks

  • OxaliplatinDrug

    Also called Eloxatin

    85 mg/m², d1 every 2 weeks

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2, d1 every 3 weeks

  • DocetaxelDrug

    Also called Taxotere

    50mg/m2, d1 every 2 weeks

Study groups in NCT01222312
Study groupRoleWhat they receive
Arm A cisplatinActive comparatorCisplatin 75 mg/m2, d1 Docetaxel 75 mg/m2, d1 every 3 weeks (d22) max. 6 cycles
Receives: Drug: Cisplatin; Drug: Docetaxel
Arm B oxaliplatinExperimentalOxaliplatin 85 mg/m², d1 Docetaxel 50mg/m2, d1 every 2 weeks (d15) max. 8 cycles
Receives: Drug: Oxaliplatin; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. response rate

    Measured: staging every 2 months

Secondary outcomes (5)

  1. 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

    Measured: every two weeks

  2. quality of life

    Measured: every 8 weeks

  3. progression free survival PFS

    Measured: every 2 months

  4. overall survival OS

    Measured: 6 months follow-up

  5. time to treatment failure TTF

    Measured: every two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2010 (estimated)
  2. Study startAug 2008
  3. Primary completionOct 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01222312
Sponsor's protocol ID
S417
Acronym
Taxelox
Status last verified
Nov 2011
First submitted
12 Apr 2010
Last updated
29 Nov 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Oxaliplatin and Docetaxel in people with Non Small Cell Lung Cancer, run by Krankenhaus Nordwest at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

response rate (time frame: staging every 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01222312.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.

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