Status:
TERMINATED
Trial to Evaluate Paclitaxel Plus RAD001 in Urothelial Carcinoma
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single arm open- label phase II- trial evaluating safety and efficacy of paclitaxel and RAD001 in patients with metastatic urothelial bladder cancer who failed prior platin-based systemic th...
Detailed Description
The screening phase for checking eligibility and evaluation of the patient prior start of study treatment will last up to 21 days.Tumor histology must be predominant urothelial carcinoma and confirmed...
Eligibility Criteria
Inclusion
- Patients with histologically proven carcinoma of the urinary tract including urinary bladder, ureter, renal pelvis and lower urinary tract. Urothelial carcinoma should be the predominant histology
- Confirmation of locally relapsed or metastatic disease by imaging. Measurable disease according to RECIST- guidelines with ≥1 measurable lesion has to be evident.
- If bone is the only metastatic site a quantification of the target lesion(s) using MRI is mandatory.
- Failure of prior platin- based chemotherapy
- Patients may have shown progressive disease within the first 3 months of platin-based chemotherapy (primary failure) or progression within 3 months after the end of platin-based chemotherapy (early relapse)-Prior therapy with ≤ 4 chemotherapeutic drugs
- Patients with tumor relapse within 3 months after cystectomy in the neoadjuvant or adjuvant setting are not eligible.
- ECOG performance status 0-2
- Adequate haematological, liver and renal functions.
- Neutrophil count \> 1500/mm3, haemoglobin \> 9 g/dl, platelets ≥ 100.000/ mm3
- Serum bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN. Patients with known liver metastases who have an AST and ALT ≤ 5x ULN.
- serum creatinine ≤ 2 x ULN.
- Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to the first dose of study drug. Female subjects of childbearing potential must be using two acceptable methods of contraception, from the time of screening and for the duration of the study, through study completion and for 3 months following study completion
- Age \> 18 years.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- Patients must give written informed consent
- No concurrent treatment with other experimental drugs or anti-cancer drugs
- Another distinguishable malignancy will be permitted
Exclusion
- chemotherapy, radiation therapy or any other anticancer therapy within 4 weeks of the first dose of study drug.
- Participation in any clinical investigation within 4 weeks prior to initial dosing.
- known hypersensitivity to RAD001 or other rapamycin analogs and paclitaxel or other taxanes, or to its excipients.
- previously received RAD001, other mTOR inhibitors or taxanes or epothilones
- known metastasis of central nervous system.
- symptomatic pleural effusions or symptomatic ascites.
- wide field radiation therapy to up to ≥ 25% of the bone marrow within 4 weeks prior therapy.
- intravenous radionuclide therapy, e.g. phosphorus (32P), strontium (89SrCl), rhenium (186Re)or samarium (153Sm).
- Patients who have undergone major surgery within 4 weeks prior to starting study drug,open biopsy, or significant traumatic injury, or who have not recovered from the side effects of any of the above.
- Chronic systemic treatment with corticosteroids corresponding to a prednisone equivalent of \> 10 mg daily. Patients receiving corticosteroids must be on a stable dose for ≥ 4 weeks prior to the first dose of RAD001. Topical or inhaled corticosteroids are permitted.
- Concomitant medication with strong CYP3A4- inhibitors or CYP3A4- inducers.
- active bleeding diathesis.
- Neuropathy \> grade 1.
- any severe and/or uncontrolled medical conditions(unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months, serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled severe infection,cirrhosis,chronic or persistent active hepatitis)
- severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation ≤ 88% at rest on room air
- Uncontrolled diabetes
- Hepatic impairment with a Child-Pugh score \>9
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00933374
Start Date
July 1 2009
End Date
September 1 2013
Last Update
March 18 2015
Active Locations (6)
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1
Klinik für Urologie, Klinikum rechts der Isar der TU München
München, Bavaria, Germany, 81675
2
Universitätsklinik Hamburg, Medizinische Klinik und Poliklinik Onkologie - Hämatologie
Hamburg, Hamburg, Germany, 20246
3
Heinrich-Heine-University of Duesseldorf, Department of Urology
Düsseldorf, North Rhine-Westphalia, Germany, 40225
4
Universitätsklinik Essen, Klinik für Urologie
Essen, North Rhine-Westphalia, Germany, 45122