search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Randomized multicenter phase III study of weekly paclitaxel versus three weekly paclitaxel in patients with metastatic breast cancer previously treated with anthracyclines.


- candidate number1351
- NTR NumberNTR186
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested18-okt-2005
- Date Registered NTR1-sep-2005
- Secondary IDsN/A 
- Public TitleRandomized multicenter phase III study of weekly paclitaxel versus three weekly paclitaxel in patients with metastatic breast cancer previously treated with anthracyclines.
- Scientific TitleRandomized multicenter phase III study of weekly paclitaxel versus three weekly paclitaxel in patients with metastatic breast cancer previously treated with anthracyclines.
- ACRONYMN/A
- hypothesisAssessment of the progression-free survival, activity and toxicity of weekly administration of paclitaxel versus three weekly paclitaxel.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteria1. Histologically or cytologically confirmed metastatic breast cancer;
2. No past or current history of another neoplastic disease, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix uteri, or other cancers cured by surgery alone and with a disease-free interval of longer than 5 years;
3. Measurable or evaluable metastatic disease outside irradiated areas; lesions in previously irradiated areas can be considered measurable if they are clearly progressing before study entry and the interval between the radiotherapy and the start of protocol treatment exceeds 3 months;
4. Prior treatment with an anthracycline, while further treatment with an anthracycline is judged to be of no benefit;
5. Age °› 18 and °‹80 years;
6. WHO performance status °‹ 2;
7. Life expectancy of at least 3 months;
8. Interval from major surgery, radiotherapy or prior cytotoxic treatment of at least 4 weeks;
9. Patients must have recovered from all adverse effects of prior treatment that could interfere with the antitumor activity or toxicity assessment of the protocol treatment, besides alopecia;
10. Adequate hematologic, renal and hepatic function as defined by the following required laboratory values (obtained °‹ 14 days prior to study enrolment): Absolute neutrophil count (ANC) °› 1.5 x 109/L. Platelets °› 100 x 109/L. Serum creatinine< 1.5 x upper normal limit or creatinine clearance >40 ml/min. Total bilirubin °‹1.5 x upper normal limit. SGOT (ASAT) and/or SGPT (ALAT) °‹ 2.5 x upper normal limit;
11. Patients must be assessable for treatment, quality of life and follow-up;
12. Informed consent obtained according to the local Ethics Committee requirements.
- Exclusion criteria1. Prior treatment with taxanes;
2. Pregnant or breast-feeding females, or females of child-bearing potential not taking adequate methods of birth control;
3. The presence of significant cardiac disease, i.e. hypertension not responding to treatment, unstable angina, congestive heart failure, myocardial infarction within the previous year, cardiac ventricular arrhytmias or a history of a 2nd or 3rd degree heart block without a pacemaker in situ;
4. The presence of CTC grade 2 peripheral neurotoxicity;
5. The presence of leptomeningeal or CNS metastases;
6. Any other condition or therapy that, in the investigatorís opinion, may pose a risk to the patient or interfere with the study objectives, including any other medication that, in the investigators opinion, could compromise the well-being of the patient or the outcome of the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2000
- planned closingdate1-jan-2005
- Target number of participants160
- InterventionsArm A: weekly paclitaxel 80 mg/m2 i.v.;
Arm B (standard arm): three weekly paclitaxel 175 mg/m2 i.v.
- Treatment until progression, unacceptable toxicity.
- Primary outcomeProgression-free survival.
- Secondary outcome1. Overall survival;
2. response rate;
3. toxicity;
4. quality of life.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. N. Groeningen, van
- CONTACT for SCIENTIFIC QUERIESDr. N. Groeningen, van
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD1-sep-2005 - 23-jun-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl