Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma

• Status: Completed
• Trial end date: 2017-10-13
• Target enrollment: 0
• Participant gender: Male

Summary

This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a complete response patients received 3 cycles of treatment. If the PET - CT scan did not show a complete response patients received 4 cycles of treatment. After treatment, patients were followed up for 2 years.

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

Details

• Lead Sponsor: Barts & The London NHS Trust
• Collaborator: University College London Hospitals
• Treatments: Carboplatin

Criteria

Inclusion Criteria:

1. Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG) good prognosis.

2. Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance over 25 ml/min.

3. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3.

4. Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable).

5. Males aged ≥18 and ≤75 years.

6. Able to give written informed consent prior to study entry.

7. Patients must be sterile or agree to use adequate contraception during the period of therapy.

Exclusion Criteria:

1. Metastatic seminoma with any non-pulmonary visceral metastases.

2. Raised Alpha-fetoprotein.

3. Any previous chemotherapy or radiotherapy.

4. Currently enrolled in any other investigational drug study.

5. Other malignancy except basal cell.