Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

Phase 2

Completed

• Conditions: Cancer
• Interventions: Drug: CYCLOPHOSPHAMIDE; Drug: MEGESTROL

• Registration Number: NCT00420563
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-01-09
• Study First Submitted QC: 2007-01-09
• Study First Posted: 2007-01-11
• Primary Completion: 2009-01
• Study Completion: 2009-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-20
• Last Update Posted: 2012-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	-
MEGESTROL	MEGESTROL	-

Primary Outcome Measures

Name	Time	Method
Progression free survival rate at 2 months	2 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Centre Oscar Lambret; 🇫🇷 Lille, France

Hopital Saint Vincent; 🇫🇷 Lille, France

Centre Hospitalier Regional - Dermatology; 🇫🇷 Lille, France

Centre Hospitalier Regional - Oncology; 🇫🇷 Lille, France