Status:
COMPLETED
Everolimus for Patients With Relapsed/Refractory Germ Cell Cancer
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Novartis
Conditions:
Testicular Cancer
Germ Cell Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the drug everolimus is effective in the treatment of patients with relapsed cancer of the testis. This is a phase II study where all patients will rec...
Detailed Description
Rationale Patients with metastatic germ cell cancer and relapse after two or more courses of cisplatin-based chemotherapy or after high-dose chemotherapy have a poor prognosis and few treatment optio...
Eligibility Criteria
Inclusion
- Male patients \>= 18 years old.
- Patients with histologically proven seminomatous or non-seminomatous germ cell cancer
- Disease progression during cisplatin-based chemotherapy or
- Disease progression or relapse after high-dose chemotherapy or
- Disease progression or relapse after at least 2 different cisplatin-based regimens and contraindications for high-dose chemotherapy.
- Patients must have received prior combination chemotherapy with gemcitabine, oxaliplatin and paclitaxel (GOP). Prior treatment with a combination of two of these drugs is allowed in case of contraindications for GOP.
- Disease progression at study entry: progressive disease according to RECIST criteria in baseline examinations or tumor marker increase \> 25% within 4 weeks before study entry.
- ECOG performance status \<= 2.
- Life expectancy \>= 3 months.
- Adequate bone marrow function: absolute neutrophil count \>= 1.5 x 109/1, platelets \>= 75 x 109/1, hemoglobin \>= 9 g/dl.
- Adequate liver function: serum bilirubin: \<= 1.5x ULN, ALT and AST \<= 2.5x ULN. For patients with known liver metastases: AST and ALT \<= 5x ULN.
- Adequate renal function: serum creatinine \<= 2.0x ULN.
- Patients must be surgically sterile or must agree to use effective contraception during study treatment.
- Signed written informed consent.
Exclusion
- Systemic antitumor treatment within 21 days before study entry.
- Simultaneous radiotherapy of the only target lesion(s).
- Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above
- Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus, everolimus).
- Patients receiving chronic systemic treatment with corticosteroids (dose of \>= 20 mg/day methylprednisone equivalent) or another immunosuppressive agent.
- Patients with unstable angina pectoris, myocardial infarction \<= 6 months prior to first study treatment, congestive heart failure NYHA III-IV or serious uncontrolled cardiac arrhythmias.
- Patients with severely impaired lung function: spirometry or DLCO \< 50% of the normal predicted value.
- Uncontrolled diabetes: fasting serum glucose \> 2.0x ULN.
- Patients with an active or uncontrolled infection, incl. chronic Hepatitis B or C
- Patients who have a history of another primary malignancy and are off treatment for \<= 3 years, with the exception of non-melanoma skin cancer.
- Patients who have participated in another clinical trial within 30 days before study entry.
- Other serious medical conditions that could impair the ability of the patient to participate in the study.
- Patients unwilling or unable to comply with the protocol.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01242631
Start Date
November 1 2010
End Date
March 1 2014
Last Update
February 25 2015
Active Locations (8)
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1
Vivantes Klinikum am Urban
Berlin, Germany, 10967
2
Universitatsklinikum Essen
Essen, Germany, 45122
3
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
4
Hannover Medical School
Hanover, Germany, 30625