Metronomic Chemotherapy by Cyclophosphamide Versus Megest... | NCT00420563

Studies
Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

NCT00420563

Sponsor

Centre Oscar Lambret

Status

Completed

Last Update Posted

Mar 16, 2026Actual

Enrollment

88Actual

Phase

Phase 2

Conditions

Cancer

Interventions

CYCLOPHOSPHAMIDE
MEGESTROL

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2009Actual

Primary Completion Date

Jan 19, 2011Actual

Completion Date

Jan 19, 2011Actual

First Submitted Date

Jan 9, 2007

First Submission Date that Met QC Criteria

Jan 9, 2007

First Posted Date

Jan 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2026

Last Update Posted Date

Mar 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CYCLOPHOSPHAMIDE	Experimental		Drug: CYCLOPHOSPHAMIDE
MEGESTROL	Active Comparator		Drug: MEGESTROL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CYCLOPHOSPHAMIDE	Drug	50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision	CYCLOPHOSPHAMIDE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival rate at 2 months		2 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PENEL Nicolas, MD	Centre Oscar Lambret	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Oscar Lambret		Lille		59020	France
Hopital Saint Vincent

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003520	Cyclophosphamide
D008535	Megestrol

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Browse Leaves

Not provided

Browse Branches

Not provided