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

This study has been completed.
Information provided by (Responsible Party):
Centre Oscar Lambret Identifier:
First received: January 9, 2007
Last updated: July 20, 2012
Last verified: July 2012
The scope of the trial is to assess the free progression rate at 2 months for each group of patients.

Condition Intervention Phase
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Progression free survival rate at 2 months [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 88
Study Start Date: September 2006
Study Completion Date: July 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00420563

Centre Oscar Lambret
Lille, France, 59020
Hopital Saint Vincent
Lille, France, 59020
Centre Hospitalier Regional - Dermatology
Lille, France, 59035
Centre Hospitalier Regional - Oncology
Lille, France, 59035
Sponsors and Collaborators
Centre Oscar Lambret
Principal Investigator: PENEL Nicolas, MD Centre Oscar Lambret
  More Information

Responsible Party: Centre Oscar Lambret Identifier: NCT00420563     History of Changes
Other Study ID Numbers: PAL-ANGI 0601
Study First Received: January 9, 2007
Last Updated: July 20, 2012

Keywords provided by Centre Oscar Lambret:
Cancer, palliative treatment

Additional relevant MeSH terms:
Megestrol Acetate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Appetite Stimulants
Central Nervous System Stimulants processed this record on May 25, 2017