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van CCT (UK)


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van CCT (UK)


Open label randomized phase III study of weekly docetaxel and docetaxel every 3 weeks in patients with metastatic breast cancer, resistant to prior chemotherapy.


- candidate number6281
- NTR NumberNTR1944
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2009
- Secondary IDsMETC AMC 2000/167 METC UMCG 2000/132
- Public TitleOpen label randomized phase III study of weekly docetaxel and docetaxel every 3 weeks in patients with metastatic breast cancer, resistant to prior chemotherapy.
- Scientific TitleOpen label randomized phase III study of weekly docetaxel and docetaxel every 3 weeks in patients with metastatic breast cancer, resistant to prior chemotherapy.
- ACRONYMTAX 613
- hypothesisIs docetaxel weekly as effective and less toxic than the same dose given 3-weekly.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteria1. Histologically or cytologically proven breast adenocarcinoma;
2. Evaluable or measurable disease according to RECIST criteria;
3. Metastatic progressive breast cancer;
4. No more than 1 line of chemotherapy for metastatic disease;
5. Radiotherapy is allowed, no minimum time interval between the end of radiotherapy and study entry , however the irradiated lesion must not be the only lesion to evaluate response;
6. Performance status ECOG < 2;
7. Adequate liver function defined by:
A. Single abnormalities:
- Total bilirubin < upper normal limit;
- Transaminases < 3.5x upper normal limits;
- Alkaline phosphatase < 6x upper normal limit.
B. Combined abnormalities:
- If transaminase levels are between 1.5x and 3,5 x upper normal limits and Alkaline phosphatase is between 2.5x and 6x upper normal limits, starting dosage should be reduced with 25%;
- NOTE : patients with ASAT/ALAT >3,5 x ULN associated with ALP>6x ULN are not eligible for study.
8. Written informed consent given;
9. Age >18 years. • Compliance with follow up requirements
- Exclusion criteria1. ECOG > 2;
2. Prior exposure to taxanes for metastatic disease;
3. Patient who received two or more lines of prior chemotherapy for metastatic disease;
4. Inadequate bone marrow function:
A. Neutrophils < 1.5 x 109/L;
B. Platelets <100 x 109/L.
5. Inadequate liver function defined by:
A. Total bilirubin > UNL;
6. Concurrent severe and/or co-morbid medical condition;
7. Concurrent treatment with other experimental drugs or clinical trials;
8. Definite contraindications for the use of corticosteroïds;
9. Pregnant or lactating women;
10. Symptomatic peripheral neuropathy > NCI-CTC grade II;
11. Hormonal treatment (prior hormonal treatment allowed).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 18-jul-2000
- planned closingdate1-jan-2008
- Target number of participants150
- InterventionsTwo different regimens.
- Primary outcome1. PFS;
2. TTF.
- Secondary outcomeOS.
- Timepoints> 50% participants deceased.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. A.M. Westermann
- CONTACT for SCIENTIFIC QUERIESProf. Dr. PHB Willemse
- Sponsor/Initiator Aventis
- Funding
(Source(s) of Monetary or Material Support)
Aventis
- PublicationsN/A
- Brief summaryWeekly taxotere vs 3-weekly taxotere, compare Side effects and anti-tumor activity.
- Main changes (audit trail)
- RECORD5-aug-2009 - 11-okt-2009


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