First Line TIP in Poor Prognosis TGCTs.

National Cancer Institute, Slovakia

Status and phase: Completed; Phase 2

Conditions: Germ Cell Tumor

Treatments: Drug: Paclitaxel; Drug: Cisplatin; Drug: Ifosfamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02414685

GCTSK003

Details and patient eligibility

About

TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Full description

Cycle 1: BEP regimen

Serum tumor markers at day 18-21:

•Patients with an unfavorable pattern of tumor marker decrease after 1 cycle of BEP will receive 4 more cycles of TIP.

TIP regimen:

• Taxol 250 mg/ m2 iv on day 1
• Ifosfamid 1,2 g/ m2/ day iv x 5 days
• Cisplatin 20 mg/ m2/ day iv x 5 days One cycle of therapy consists of 22 days. Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Enrollment: 19 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients older than 16 years.
• Evidence of NSGCT based on histologic examination or based on clinical evidence and high serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are very elevated)
• Testicular, retroperitoneal, or mediastinal primary site.
• Evidence of disseminated disease (clinical stages II or III).
• Disease classified as poor prognosis according to IGCCCG criteria:
• Primary mediastinal NSGCT or
• Non-pulmonary visceral metastases or
• HCG > 50,000 UI/l, or AFP > 10,000 ng/ml, or LDH > 10 times the upper normal value.
• No prior chemotherapy.
• No previous carcinoma, except basal-cell carcinoma of the skin.
• Adequate renal function: measured or calculated creatinine clearance> 60 ml/min.
• Absolute granulocyte count >= 1,500/mm3, platelets >= 100,000 mm3, bilirubine <= 1.5 fold the upper normal value.
• Unfavorable tumor marker decline after 1.cycle of BEP
• Signed informed consent.

Exclusion criteria

• Patients infected by the Human Immunodeficiency Virus (HIV).
• Patients who do not fit inclusion criteria.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

intravenous chemotherapy

Experimental group

Description:

TIP regimen: * Paclitaxel 250 mg/ m2 iv on day 1 * Ifosfamide 1,2 g/ m2/ day iv x 5 days * Cisplatin 20 mg/ m2/ day iv x 5 days

Treatment:

Drug: Ifosfamide

Drug: Cisplatin

Drug: Paclitaxel