First Line TIP in Poor Prognosis TGCTs.

NCT02414685 | Completed Phase 2 DMC

• 1 other identifier: GCTSK003
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Germ Cell Tumor

Keywords

poor-prognosis germ cell cancer, paclitaxel, ifosfamid and cisplatin regimen, tumor marker decline

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  according RECIST criteria version 1.1

  36 month

Secondary Outcomes (4)

• Response rate

  36 month

• Progression-free survival

  36 month

• Number of adverse events grade III and IV

  36 month

• overall survival

  36 months

Study Arms (1)

intravenous chemotherapy

EXPERIMENTAL

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; Drug: Ifosfamide; Drug: Cisplatin

Interventions

Paclitaxel DRUG

paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements

Also known as: paclitaxel ebewe

intravenous chemotherapy

Ifosfamide DRUG

paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements

Also known as: ifosfamide-holoxan

intravenous chemotherapy

Cisplatin DRUG

paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements

Also known as: cisplatin-hospira

intravenous chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients infected by the Human Immunodeficiency Virus (HIV).

Sponsors & Collaborators

• National Cancer Institute, Slovakia: lead

Study Sites (1)

National Cancer Institute

Bratislava, 83310, Slovakia

Location

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

Paclitaxel; Ifosfamide; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Michal Mego, Ass.prof

  National Cancer Institute, Slovakia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 13, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Locations

SL (1)