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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00772694
Recruitment Status : Unknown
Verified October 2008 by Fondation Wygrajmy Zdrowie.
Recruitment status was:  Recruiting
First Posted : October 15, 2008
Last Update Posted : October 24, 2008
Information provided by:
Fondation Wygrajmy Zdrowie

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.

Condition or disease Intervention/treatment Phase
Testicular Cancer Drug: sorafenib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
Study Start Date : September 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arm Intervention/treatment
Experimental: sorafenib
Drug: sorafenib
tablets 200mg, 400mg bid continuously in 4-week cycles
Other Name: Nexavar

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: one year ]

Secondary Outcome Measures :
  1. ORR Evaluation of the usefulness the CT with vasculature visualisation option in the measurement of the objective response Evaluation of quality of life [ Time Frame: one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00772694

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Contact: Iwona A Skoneczna, MD +48225462098
Contact: Agnieszka Chaladaj-Kujawska, MD +48225462057

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Chemotherapy Unit, Dept of Urology, Instituite of Oncology Recruiting
Warsaw, Poland, 02781
Principal Investigator: Iwona A Skoneczna, MD         
Sub-Investigator: Agnieszka Chaladaj-Kujawska, MD         
Sponsors and Collaborators
Fondation Wygrajmy Zdrowie
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Responsible Party: dr Iwona Skoneczna, Fondation Wygrajmy Zdrowie Identifier: NCT00772694    
Other Study ID Numbers: 12602
PL/ 183/UR/CEBK/04/08
EudraCT 2007-007599-40
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: October 2008
Keywords provided by Fondation Wygrajmy Zdrowie:
testicular cancer
germ cell cancer
Additional relevant MeSH terms:
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Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action