Everolimus for Patients With Relapsed/Refractory Germ Cell Cancer

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Male

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 receive the study drug (everolimus 10 mg daily). The primary endpoint of the study is the rate of patients that have no progressive disease after 12 weeks of treatment. Twenty-five evaluable patients will be treated in this study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hannover Medical School
• Collaborator: Novartis
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.