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Completed

NCT Number: NCT00420563

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Regional - Dermatology, Lille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

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

Megestrol

Drug

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

Primary outcomes

  1. Progression free survival rate at 2 months

    Time frame: 2 months

Secondary outcomes

  1. Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months

    Time frame: After 2, 4 and 6 months of treatment

  2. Toxicity according to NCI scale v3.0

    Time frame: During study treatment

  3. Biological markers

    Time frame: the 2 first months of treatment

  4. Overall survival

    Time frame: Until death of the patient or until study analysis

  5. Median time between the beginning of treatment and hospitalization due to progression or toxicity

    Time frame: time of the study

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Acronym: PAL-ANGI

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2007
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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