| March 5, 2008 |
| April 3, 2009 |
| July 2006 |
| December 2009 (final data collection date for primary outcome measure) |
| Response rate [ Time Frame: Every 3 courses ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00634205 on ClinicalTrials.gov Archive Site |
- Survival [ Time Frame: Survival will be dated from the day of registration until death or last follow up ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: After each course of chemotherapy and at the end of treatment ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma |
| A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma |
The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives . |
| |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Malignant Mesothelioma |
| Drug: Valproate plus doxorubicin |
| Experimental: Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin |
| |
| |
| Active, not recruiting |
| 41 |
| June 2010 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Histological diagnosis of malignant mesothelioma
- Unresectable or inoperable malignant mesothelioma failing after at least one prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin)
- At least one evaluable or measurable CT-lesion
- Availability for participating in the detailed follow-up of the protocol
- Signed informed consent
Exclusion Criteria:
- Patients who are candidates for surgery with curative intent
- Patient who were previously treated with anthracyclin derivatives
- Performance status < 60 on the Karnofsky scale
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
- A history of prior HIV infection
- Polynuclear cells < 2,000/mm³
- Platelet cells < 100,000/mm³
- Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen
- Serum bilirubin >1.5 mg/100 ml
- Transaminases more than twice the normal range
- Serum creatinine > 1.5 mg/100 ml
- Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- Congestive cardiac failure (ejectional fraction of the left ventricle < 50%) or uncontrolled cardiac arrhythmia
- Uncontrolled infectious disease
- Active epilepsy needing a specific treatment
- Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine
- Pregnancy or refusal to use active contraception
- A known allergy to valproate acid and/or doxorubicin
- Serious medical or psychological factors which may prevent adherence to the treatment schedule
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, France |
| |
| NCT00634205 |
| Dr Thierry Berghmans, European Lung Cancer Working Party |
| ELCWP-01062 |
| European Lung Cancer Working Party |
|
| Study Chair: |
Thierry Berghmans, MD |
European Lung Cancer Working Party |
|
|
| European Lung Cancer Working Party |
| April 2009 |
