Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

Phase 2CompletedNCT00420563

Centre Oscar Lambret88 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

CYCLOPHOSPHAMIDEDRUG

50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision

MEGESTROLDRUG

320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Centre Oscar Lambret

Lille, France

Hopital Saint Vincent

Lille, France

Centre Hospitalier Regional - Dermatology

Lille, France

Centre Hospitalier Regional - Oncology

Lille, France

Outcomes

Primary Outcomes

Progression free survival rate at 2 months

Time frame: 2 months

Secondary Outcomes

Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months

Time frame: After 2, 4 and 6 months of treatment

Toxicity according to NCI scale v3.0

Time frame: During study treatment

Biological markers

Time frame: the 2 first months of treatment

Overall survival

Time frame: Until death of the patient or until study analysis

Median time between the beginning of treatment and hospitalization due to progression or toxicity

Time frame: time of the study

Data from ClinicalTrials.gov

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