First Line TIP in Poor Prognosis TGCTs. (TIP)

A Treatment Strategy of the Use of 1st Line Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors Based on Tumor Marker Decline: A Phase II Trial of Paclitaxel, Ifosfamid and Cisplatin Regimen.

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.

Study Overview

• Status: Completed
• Conditions: Germ Cell Tumor
• Intervention / Treatment: Drug: Paclitaxel; Drug: Ifosfamide; Drug: Cisplatin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• Slovakia
  • Bratislava, Slovakia, 83310
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: intravenous chemotherapy; 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

Drug: Paclitaxel; paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements; Other Names: paclitaxel ebewe; Drug: Ifosfamide; paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements; Other Names: ifosfamide-holoxan; Drug: Cisplatin; paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements; Other Names: cisplatin-hospira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate	according RECIST criteria version 1.1	36 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate	36 month
Response rate	response rate after chemotherapy	36 month
Number of adverse events grade III and IV		36 month
overall survival	Survival will be estimated from the registration date to the date of last follow-up or death. Patients will be followed at least 3 years.	36 months

Collaborators and Investigators

• Sponsor: National Cancer Institute, Slovakia
• Investigators: Study Chair: Michal Mego, Ass.prof, National Cancer Institute, Slovakia

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: April 10, 2015
• First Posted (Estimate): April 13, 2015

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: poor-prognosis germ cell cancer, paclitaxel, ifosfamid and cisplatin regimen, tumor marker decline
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin; Ifosfamide; Isophosphamide mustard; Albumin-Bound Paclitaxel
• Other Study ID Numbers: GCTSK003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED