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

Sponsor

Centre Oscar Lambret (Other)

Overall Status

Completed

CT.gov ID

NCT00420563

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: CYCLOPHOSPHAMIDE Drug: MEGESTROL	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CYCLOPHOSPHAMIDE	Drug: CYCLOPHOSPHAMIDE 50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision
Active Comparator: MEGESTROL	Drug: MEGESTROL 320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision

Arm

Intervention/Treatment

Experimental: CYCLOPHOSPHAMIDE

Drug: CYCLOPHOSPHAMIDE

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

Active Comparator: MEGESTROL

Drug: MEGESTROL

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

Outcome Measures

Primary Outcome Measures

Progression free survival rate at 2 months [2 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Oscar Lambret	Lille	France	59020
2	Hopital Saint Vincent	Lille	France	59020
3	Centre Hospitalier Regional - Dermatology	Lille	France	59035
4	Centre Hospitalier Regional - Oncology	Lille	France	59035

Sponsors and Collaborators

Centre Oscar Lambret

Investigators

Principal Investigator: PENEL Nicolas, MD, Centre Oscar Lambret

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Oscar Lambret

ClinicalTrials.gov Identifier:

NCT00420563

Other Study ID Numbers:

PAL-ANGI 0601

First Posted:

Jan 11, 2007

Last Update Posted:

Jul 23, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Centre Oscar Lambret

Cancer, palliative treatment

Additional relevant MeSH terms:

Cyclophosphamide

Megestrol

Study Results

No Results Posted as of Jul 23, 2012