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A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival rate at 2 months

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

PENEL Nicolas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Oscar Lambret

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

PAL-ANGI 0601

NCT ID:

NCT00420563

Start Date:

September 2006

Completion Date:

July 2009

Related Keywords:

  • Cancer
  • Cancer, palliative treatment

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