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

Primary Purpose

Testicular Cancer

Status
Unknown status
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
sorafenib
Sponsored by
Fondation Wygrajmy Zdrowie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Testicular Cancer focused on measuring testicular cancer, germ cell cancer, sorafenib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Chemotherapy Unit, Dept of Urology, Instituite of OncologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sorafenib

Arm Description

drug

Outcomes

Primary Outcome Measures

Progression free survival

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

Full Information

First Posted
October 14, 2008
Last Updated
October 23, 2008
Sponsor
Fondation Wygrajmy Zdrowie
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1. Study Identification

Unique Protocol Identification Number
NCT00772694
Brief Title
Sorafenib Monotherapy in Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
Acronym
GCT
Official Title
Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fondation Wygrajmy Zdrowie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Cancer
Keywords
testicular cancer, germ cell cancer, sorafenib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sorafenib
Arm Type
Experimental
Arm Description
drug
Intervention Type
Drug
Intervention Name(s)
sorafenib
Other Intervention Name(s)
Nexavar
Intervention Description
tablets 200mg, 400mg bid continuously in 4-week cycles
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
one year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients > 18 years of age Patients with histologically proven germ cell neoplasm (gonadal or extragonadal primary) Patients must have the disease not amendable to cure with either surgery or chemotherapy Patients must have failed at least two cisplatin-based combination chemotherapy regimens. 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. Patients with at least one measurable lesion by CT scan or MRI according to RECIST criteria 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 WHO Performance Status 0, 1, 2 No concurrent chemotherapy or radiotherapy Life expectancy of at least 12 weeks Absence of any physiological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule A signed informed consent must be obtained prior to any study specific procedures All patients must agree to use adequate contraception during the whole study period Exclusion Criteria: Patients not fulfilling of inclusion criteria Primary radiotherapy in the field of target lesion Major surgery (RPLND) within 4 weeks before the start of study drug or concurrent serious non-healing wounds, ulcers or bone fractures. Known serious and active bacterial, viral or fungal infection (> grade II CTC-AE) including HBV, HCV and HIV carrier state. Previous or concurrent malignancy except for basal cell carcinoma of the skin Uncontrolled hypertension. Thrombotic or embolic event in last 6 months prior to inclusion. Impairment of gastrointestinal tract, or GI disease that may influence the bioavailability of oral sorafenib Substance and alcohol abuse (nicotine use is allowed) Known or suspected hypersensitivity to sorafenib. Participants in any other clinical trial using investigational drug within 4 weeks prior to study entry Prior use of investigational or licensed angiogenesis and RAF kinase or MEK inhibitors. Patient unwilling or unable to give informed consent Any condition that may in the investigator's opinion jeopardize the safety of the patient or his compliance in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iwona A Skoneczna, MD
Phone
+48225462098
Email
i.skoneczna@coi.waw.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Agnieszka Chaladaj-Kujawska, MD
Phone
+48225462057
Facility Information:
Facility Name
Chemotherapy Unit, Dept of Urology, Instituite of Oncology
City
Warsaw
ZIP/Postal Code
02781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iwona A Skoneczna, MD
First Name & Middle Initial & Last Name & Degree
Agnieszka Chaladaj-Kujawska, MD

12. IPD Sharing Statement

Learn more about this trial

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

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