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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00420563
First received: January 9, 2007
Last updated: July 20, 2012
Last verified: July 2012

January 9, 2007
July 20, 2012
September 2006
January 2009   (final data collection date for primary outcome measure)
Progression free survival rate at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Toxicity according to NCI scale v3.0 [ Time Frame: During study treatment ] [ Designated as safety issue: Yes ]
  • Biological markers [ Time Frame: the 2 first months of treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until death of the patient or until study analysis ] [ Designated as safety issue: No ]
  • Median time between the beginning of treatment and hospitalization due to progression or toxicity [ Time Frame: time of the study ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00420563
PAL-ANGI 0601
Yes
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