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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Fondation Wygrajmy Zdrowie.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fondation Wygrajmy Zdrowie
ClinicalTrials.gov Identifier:
NCT00772694
First received: October 14, 2008
Last updated: October 23, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Testicular Cancer
Drug: sorafenib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy

Resource links provided by NLM:


Further study details as provided by Fondation Wygrajmy Zdrowie:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sorafenib
drug
Drug: sorafenib
tablets 200mg, 400mg bid continuously in 4-week cycles
Other Name: Nexavar

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772694

Contacts
Contact: Iwona A Skoneczna, MD +48225462098 i.skoneczna@coi.waw.pl
Contact: Agnieszka Chaladaj-Kujawska, MD +48225462057

Locations
Poland
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
  More Information

No publications provided

Responsible Party: dr Iwona Skoneczna, Fondation Wygrajmy Zdrowie
ClinicalTrials.gov Identifier: NCT00772694     History of Changes
Other Study ID Numbers: 12602, PL/ 183/UR/CEBK/04/08, EudraCT 2007-007599-40
Study First Received: October 14, 2008
Last Updated: October 23, 2008
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Fondation Wygrajmy Zdrowie:
testicular cancer
germ cell cancer
sorafenib

Additional relevant MeSH terms:
Testicular Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014