Sorafenib Monotherapy in Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy

Testicular Cancer Clinical Trial

— GCT  

Official title:

Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00772694
• Other study ID #: 12602
• Secondary ID: PL/ 183/UR/CEBK/
• Status: Recruiting
• Phase: Phase 2
• First received: October 14, 2008
• Last updated: October 23, 2008
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: October 2008
• Source: Fondation Wygrajmy Zdrowie
• Contact: Iwona A Skoneczna, MD
• Phone: +48225462098
• Email: i.skoneczna[@]coi.waw.pl
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

Germ cell tumors, a relatively rare disease, but most common malignancy in young males, occur most frequently in testis. The incidence is about 1%, but is increasing in the majority of developed countries. The testicular cancer is an extremely important oncological condition due to his high rate of 80-90% of curability, which can be achieved by combination of chemotherapy and surgery.

Some of 20-30% of patients will experience disease progression after first line cisplatin-based chemotherapy and salvage 2nd line conventional-dose cisplatin-based salvage chemotherapy will result in long term remissions in < 50% of patients (VeIP - vinblastine, ifosfamide, cisplatin, VIP/PEI - ifosfamide, etoposide, cisplatin, TIP - paclitaxel, ifosfamide, cisplatin). In multiple relapsed patients the 3rd line chemotherapy can induce remission in up to 40% (gemcitabine, oxaliplatin), 23% RR (TG - paclitaxel, gemcitabine), 20% CR (IPO - irinotecan, paclitaxel, oxaliplatin), but only small proportion of them can be cured, usually with subsequent consolidation surgery. At that stage the disease is usually chemorefractory and there are no other chemotherapy regimens of proven benefit (7).

The purpose of this study is to determine if multiple-relapsed chemorefractory pts may benefit from sorafenib monotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male patients > 18 years of age

2. Patients with histologically proven germ cell neoplasm (gonadal or extragonadal primary)

3. Patients must have the disease not amendable to cure with either surgery or chemotherapy

4. Patients must have failed at least two cisplatin-based combination chemotherapy regimens.

5. Failure on prior regimens will be defined as either:

• A = 25% increase in sum of target lesions, new lesions, or

• An increasing AFP or HCG above the nadir level.

6. Patients with at least one measurable lesion by CT scan or MRI according to RECIST criteria

7. Adequate bone marrow, liver and renal function, assessed no longer than 14 days before treatment start, defined by the following laboratory test limits: WBC > 2.0 x 109/l and platelets > 60 x 109/l, total bilirubin < 2 x upper limit, AST and ALT < 5 x upper limit normal, serum creatinine < 2 x UNL

8. WHO Performance Status 0, 1, 2

9. No concurrent chemotherapy or radiotherapy

10. Life expectancy of at least 12 weeks

11. Absence of any physiological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

12. A signed informed consent must be obtained prior to any study specific procedures

13. All patients must agree to use adequate contraception during the whole study period

Exclusion Criteria:

1. Patients not fulfilling of inclusion criteria

2. Primary radiotherapy in the field of target lesion

3. Major surgery (RPLND) within 4 weeks before the start of study drug or concurrent serious non-healing wounds, ulcers or bone fractures.

4. Known serious and active bacterial, viral or fungal infection (> grade II CTC-AE) including HBV, HCV and HIV carrier state.

5. Previous or concurrent malignancy except for basal cell carcinoma of the skin

6. Uncontrolled hypertension.

7. Thrombotic or embolic event in last 6 months prior to inclusion.

8. Impairment of gastrointestinal tract, or GI disease that may influence the bioavailability of oral sorafenib

9. Substance and alcohol abuse (nicotine use is allowed)

10. Known or suspected hypersensitivity to sorafenib.

11. Participants in any other clinical trial using investigational drug within 4 weeks prior to study entry

12. Prior use of investigational or licensed angiogenesis and RAF kinase or MEK inhibitors.

13. Patient unwilling or unable to give informed consent

14. Any condition that may in the investigator's opinion jeopardize the safety of the patient or his compliance in the study.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Testicular Cancer
• Testicular Neoplasms

Intervention

Drug:
• sorafenib
tablets 200mg, 400mg bid continuously in 4-week cycles

Locations

Country	Name	City	State
Poland	Chemotherapy Unit, Dept of Urology, Instituite of Oncology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Wygrajmy Zdrowie

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		one year	Yes
Secondary	ORR Evaluation of the usefulness the CT with vasculature visualisation option in the measurement of the objective response Evaluation of quality of life		one year	Yes