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
  Purpose

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


Condition Intervention Phase
Cancer
Drug: CYCLOPHOSPHAMIDE
Drug: MEGESTROL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00420563

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

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00420563     History of Changes
Other Study ID Numbers: PAL-ANGI 0601
Study First Received: January 9, 2007
Last Updated: July 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
Cancer, palliative treatment

Additional relevant MeSH terms:
Cyclophosphamide
Megestrol
Megestrol Acetate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014