Status:
COMPLETED
Carboplatin-Etoposide Combination in Hormone-Resistant Prostate Cancers
Lead Sponsor:
Centre Leon Berard
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The aim of our study is to assess the efficacy and toxicity of a chemotherapy regimen combining carboplatin and etoposide in patients with metastatic hormone-resistant prostate cancer and neuro-endocr...
Detailed Description
Neuro-endocrine differentiation is observed in the evolution of hormone-resistant prostate cancer. The aim of our study is to assess the efficacy and toxicity of a chemotherapy regimen combining carbo...
Eligibility Criteria
Inclusion
- Histological evidence of prostate adenocarcinoma
- Metastatic disease, either measurable (lymph nodes, hepatic lesion, pulmonary lesions with longest diameter \> or = 1 cm on spiral scan), or non measurable (bone metastasis)
- Patients must:
- Have received hormonal therapy via surgical or chemical castration (LH-RH agonist) with or without anti-androgens. Anti-androgen withdrawal is recommended before inclusion, with an off-treatment period of at least 4 weeks. LH-RH agonist treatment must be continued.
- Have a relapse or disease refractory to hormonal treatment (defined by a testosterone level \< 0.5 µg/ml)
- Have neuroendocrine progression defined, whatever the PSA level, as:
- NSE and/or Chromogranin A \> 1.5 x upper limit of normal (ULN) with or without visceral metastases (liver, lung, lymph node)
- No increase of NSE or Chromogranin A, but visceral metastases (either hepatic, pleuro-pulmonary, or nodal) with cytological or histological confirmation of the presence of an undifferentiated or neuro-endocrine component of prostatic origin
- Prior treatment by radiotherapy is allowed but radiation therapy must have been completed for at least 4 weeks before inclusion and irradiated areas must not represent more than 25% of marrow reserves
- Prior treatment by estramustine is allowed but must have been stopped at least 4 weeks before inclusion
- Age\> or = 18 years
- Life expectancy\> or = 3 months
- Karnofsky index\> or = 50%
- Adequate haematological function: neutrophils\> or = 1.5 G/l, platelets\> or = 100 G/l, haemoglobin\> or = 8 g/dl. Use of erythropoietin is allowed.
- Adequate liver function: bilirubin level within the institution's normal range, AST and ALT\< or = 1.5 ULN
- Adequate renal function: creatinine clearance\> or = 40 ml/min (Gault and Cockroft method)
- Signed written informed consent.
Exclusion
- Patients having no\> 1.5 x ULN increase of at least one neuro-endocrine marker (NSE or chromogranin A) and no cytological or histological (undifferentiated or neuro-endocrine type) evidence of visceral metastasis (hepatic, pleuro-pulmonary, or nodal)
- History of other malignancies, other than curatively treated basal cell skin carcinoma or any other curatively treated cancer with no sign of recurrence within 5 years
- Symptomatically uncontrolled brain metastasis
- Interstitial radiation therapy (using strontium or samarium) within the previous 3 months
- Prior treatment with platinum salts or etoposide. Other chemotherapy regimens are allowed provided that the last dose has been administered\> or = 4 weeks prior to inclusion.
- Concomitant treatment with other anti-cancer drugs, except corticoid or LH-RH agonist injections
- Peripheral neuropathy\> or = 2 (NCI-CTCAE)
- Uncontrolled progressive thrombo-embolic disease
- Uncontrolled infection
- Medical history of acute myocardial infection or uncontrolled angina pectoris, or hypertension or uncontrolled arrythmia
- Inclusion in another clinical trial
- Impaired follow-up for social, geographical, familial or psychological reasons
- Any other unstable disease.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00973882
Start Date
April 1 2005
End Date
January 1 2010
Last Update
November 3 2011
Active Locations (11)
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1
Centre François Baclesse
Caen, France, 14021
2
Hôpital Henri Mondor
Créteil, France, 94000
3
Centre Georges François Leclerc
Dijon, France, 21000
4
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, France, 85925