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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00420563 |
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Date of registration:
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09/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
PALANGI-0601 |
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Scientific title:
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A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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88 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00420563 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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PENEL Nicolas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Oscar Lambret |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Drug: CYCLOPHOSPHAMIDE
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Drug: MEGESTROL
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Primary Outcome(s)
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Progression free survival rate at 2 months
[Time Frame: 2 months]
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Secondary Outcome(s)
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Overall survival
[Time Frame: Until death of the patient or until study analysis]
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Median time between the beginning of treatment and hospitalization due to progression or toxicity
[Time Frame: time of the study]
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Toxicity according to NCI scale v3.0
[Time Frame: During study treatment]
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Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months
[Time Frame: After 2, 4 and 6 months of treatment]
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Biological markers
[Time Frame: the 2 first months of treatment]
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Secondary ID(s)
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PAL-ANGI 0601
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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