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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420563
First Posted: January 11, 2007
Last Update Posted: July 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Oscar Lambret
January 9, 2007
January 11, 2007
July 23, 2012
September 2006
January 2009   (Final data collection date for primary outcome measure)
Progression free survival rate at 2 months [ Time Frame: 2 months ]
Progression free survival rate at 2 months
Complete list of historical versions of study NCT00420563 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months
  • Toxicity according to NCI scale
  • Biological markers
  • Overall survival
  • Median time between the beginning of treatment and hospitalization
Not Provided
Not Provided
 
Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
The scope of the trial is to assess the free progression rate at 2 months for each group of patients.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cancer
  • Drug: CYCLOPHOSPHAMIDE
    50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision
  • Drug: MEGESTROL
    320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision
  • Experimental: CYCLOPHOSPHAMIDE
    Intervention: Drug: CYCLOPHOSPHAMIDE
  • Active Comparator: MEGESTROL
    Intervention: Drug: MEGESTROL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
July 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00420563
PAL-ANGI 0601
Yes
Not Provided
Not Provided
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Principal Investigator: PENEL Nicolas, MD Centre Oscar Lambret
Centre Oscar Lambret
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP