Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer (PALANGI-0601)

Centre Oscar Lambret

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Drug: CYCLOPHOSPHAMIDE; Drug: MEGESTROL

Study type: Interventional

Funder types: Other

Identifiers

NCT00420563

PAL-ANGI 0601

Details and patient eligibility

About

The scope of the trial is to assess the free progression rate at 2 months for each group of patients.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

CYCLOPHOSPHAMIDE

Experimental group

Treatment:

Drug: CYCLOPHOSPHAMIDE

MEGESTROL

Active Comparator group

Treatment:

Drug: MEGESTROL