Cancer
Conditions
Keywords
Cancer, palliative treatment
Brief summary
The scope of the trial is to assess the free progression rate at 2 months for each group of patients.
Interventions
DRUGCYCLOPHOSPHAMIDE
50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision
DRUGMEGESTROL
320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision
Sponsors
Centre Oscar Lambret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> or = 18 * PS-WHO \< or = 1 * Histologically proven cancer * No other therapeutic proposal * Treatment can be orally taken * Radiologic proof of evolutive character of the disease * Effective contraception
Exclusion criteria
* Hypercalcemia ( Ca \> 2.65 mmol/l) * Breast cancer * Thrombosis or pulmonary embolism * Dysphagia, malabsorption * Polynuclear neutrophil leukocytes \< 1000/mm3 * Treatment with Tegretol * Active and uncontrolled infection * Evolutive psychiatric disease * Pregnant or lactating woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival rate at 2 months | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months | After 2, 4 and 6 months of treatment |
| Toxicity according to NCI scale v3.0 | During study treatment |
| Biological markers | the 2 first months of treatment |
| Overall survival | Until death of the patient or until study analysis |
| Median time between the beginning of treatment and hospitalization due to progression or toxicity | time of the study |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPENEL Nicolas, MD
Centre Oscar Lambret
Outcome results
None listed