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

NCT ID: NCT01222312

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Non Small Cell Lung Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A cisplatin

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

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

75 mg/m2, d1 every 3 weeks

Docetaxel

Intervention Type DRUG

75 mg/m2, d1 every 3 weeks

Arm B oxaliplatin

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

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

85 mg/m², d1 every 2 weeks

Docetaxel

Intervention Type DRUG

50mg/m2, d1 every 2 weeks

Interventions

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Cisplatin

75 mg/m2, d1 every 3 weeks

Intervention Type DRUG

Oxaliplatin

85 mg/m², d1 every 2 weeks

Intervention Type DRUG

Docetaxel

75 mg/m2, d1 every 3 weeks

Intervention Type DRUG

Docetaxel

50mg/m2, d1 every 2 weeks

Intervention Type DRUG

Other Intervention Names

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Eloxatin Taxotere Taxotere

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Krankenhaus Nordwest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elke Jäger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Nordwest

Locations

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Krankenhaus Nordwest

Frankfurt am Main, , Germany

Site Status

Countries

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Germany

Other Identifiers

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S417

Identifier Type: -

Identifier Source: org_study_id