Ifosfamide |
Ifex |
Clinical Trial: Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent Vs. Double-Agent Vs. Triple-Agent Therapy.
This study is currently recruiting patients.
Verified by Aktion Bronchialkarzinom e.V. September 2005
|
Purpose
This study wants to assess different intensive therapy sequences for the treatment of non-small-cell lung cancer.
It claims less on the efficacy of different chemotherapy combinations, than more on the comparison of different strategies of sequential single-agent, sequential double-agent or sequential triple-agent therapy.
| Condition | Intervention | Phase |
|---|---|---|
| Non-Small-Cell Lung Carcinoma | Drug: Gemcitabine Drug: Navelbine Drug: Carboplatin Drug: Cisplatin Drug: Mitomycin Drug: Ifosfamide | Phase III |
MedlinePlus related topics: Cancer; Lung Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Secondary Outcomes: Event-free survival; Quality of live
Expected Total Enrollment: 420
Study start: June 2002
Eligibility
Inclusion Criteria:
- Histological verified non-small cell lung cancer. Cytological diagnosis is accepted for doubtless results.
- Present stage IIIb with malignant pleural effusion or stage IV disease. Tumor dissemination should not be irradiable in one field
- Age between 18 and 75 years
- Karnofsky index 70 – 100%
- Measurable or evaluable tumor parameter
- No prior chemotherapy for NSCLC
- Sufficient hematological parameter before start of therapy (leucocytes > 3.500/µl and platelets > 100.000/µl).
- Sufficient liver function (bilirubin < 1,6mg/dl)
- Sufficient renal function (creatinine < 1,5mg/dl and clearance > 60ml/min)
- Minimal estimated life expectancy > 3 months
- Written informed consent for study attendance
- Patient accessibility for therapy and follow up
- No attendance to an other study
Exclusion Criteria:
- Small-cell lung cancer oder tumors with small-cell fractions
- Local advanced irradiable stage III
- Previous chemotherapy because of other diseases, not longer than 3 years ago
- Simultaneous radiation of all present tumor manifestations
- Simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma
- Respiratory insufficiency
- Heart insufficiency NYHA III and IV
- Peripheral arteriosclerosis stage III and IV
- Neurological and psychiatric diseases, which affect understanding of the study concept and the possibility to keep conditions of the protocol
- Pregnancy, breastfeeding or not ensured contraception
- HIV-infection
- Active hepatitis B and C
- Manifest infectious diseases before start of therapy
- Minimal estimated life expectancy < 3 months
- No written informed consent of the patient for study attendance and storage and disclosure of disease data according to the protocol
Location and Contact Information
Thomas Acker, Studycoordinator ++49 (0)6421 28 66 513 ackert@med.uni-marburg.de
Germany
Klinikum Kassel GmbH, Kassel, 34125, Germany; Recruiting
Martin Wolf, MD, Study Chair, Klinikum Kassel GmbH
More Information
Last Updated: September 7, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00148395
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Ifex (Drug Digest)
- Ifosfamide (Drug Digest)

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