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

NCT ID: NCT00772694

Last Updated: 2008-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-12-31

Brief 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.

Conditions

Testicular Cancer

Keywords

testicular cancer; germ cell cancer; sorafenib

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sorafenib

drug

Group Type: EXPERIMENTAL

sorafenib

Intervention Type: DRUG

tablets 200mg, 400mg bid continuously in 4-week cycles

Interventions

sorafenib

tablets 200mg, 400mg bid continuously in 4-week cycles

Intervention Type: DRUG

Other Intervention Names

Nexavar

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fondation Wygrajmy Zdrowie

OTHER

Sponsor Role: lead

Responsible Party

Fondation Wygrajmy Zdrowie

Locations

Chemotherapy Unit, Dept of Urology, Instituite of Oncology

Warsaw, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Iwona A Skoneczna, MD

Role: CONTACT

Phone: +48225462098

Email: i.skoneczna@coi.waw.pl

Agnieszka Chaladaj-Kujawska, MD

Role: CONTACT

Phone: +48225462057

Other Identifiers

PL/ 183/UR/CEBK/04/08

Identifier Type: -

Identifier Source: secondary_id

EudraCT 2007-007599-40

Identifier Type: -

Identifier Source: secondary_id

12602

Identifier Type: -

Identifier Source: org_study_id