Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

NCT ID: NCT00420563

Last Updated: 2012-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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Cancer

Keywords

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Cancer, palliative treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CYCLOPHOSPHAMIDE

Group Type EXPERIMENTAL

CYCLOPHOSPHAMIDE

Intervention Type DRUG

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

MEGESTROL

Group Type ACTIVE_COMPARATOR

MEGESTROL

Intervention Type DRUG

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

Interventions

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CYCLOPHOSPHAMIDE

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

Intervention Type DRUG

MEGESTROL

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PENEL Nicolas, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

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Centre Oscar Lambret

Lille, , France

Site Status

Hopital Saint Vincent

Lille, , France

Site Status

Centre Hospitalier Regional - Dermatology

Lille, , France

Site Status

Centre Hospitalier Regional - Oncology

Lille, , France

Site Status

Countries

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France

Other Identifiers

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PAL-ANGI 0601

Identifier Type: -

Identifier Source: org_study_id