CancerPhase 2PALANGINCT00420563
Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
A Phase 2 study testing CYCLOPHOSPHAMIDE and MEGESTROL in people with Cancer, run by Centre Oscar Lambret at 4 sites in France.
Trial summary
The scope of the trial is to assess the free progression rate at 2 months for each group of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CYCLOPHOSPHAMIDE and MEGESTROL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesFrance
- Study dates
- 25 Sep 2009to 19 Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hypercalcemia ( Ca > 2.65 mmol/l)
- Breast cancer
- Thrombosis or pulmonary embolism
- Dysphagia, malabsorption
- Polynuclear neutrophil leukocytes < 1000/mm3
- Treatment with Tegretol
Show all 9Show fewer
- Active and uncontrolled infection
- Evolutive psychiatric disease
- Pregnant or lactating woman
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Oscar Lambret
Lille, 59020
Hopital Saint Vincent
Lille, 59020
Centre Hospitalier Regional - Dermatology
Lille, 59035
Centre Hospitalier Regional - Oncology
Lille, 59035
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- CYCLOPHOSPHAMIDE, MEGESTROL
- Keywords
- Cancer, palliative treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYCLOPHOSPHAMIDEDrug
50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision
MEGESTROLDrug
320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision
| Study group | Role | What they receive |
|---|---|---|
| CYCLOPHOSPHAMIDE | Experimental | Not described Receives: Drug: CYCLOPHOSPHAMIDE |
| MEGESTROL | Active comparator | Not described Receives: Drug: MEGESTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival rate at 2 months
Measured: 2 months
Secondary outcomes (5)
Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months
Measured: After 2, 4 and 6 months of treatment
Toxicity according to NCI scale v3.0
Measured: During study treatment
Biological markers
Measured: the 2 first months of treatment
Overall survival
Measured: Until death of the patient or until study analysis
Median time between the beginning of treatment and hospitalization due to progression or toxicity
Measured: time of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study start25 Sep 2009
- Primary completion19 Jan 2011
- Study completion19 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PENEL Nicolas, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420563
- Sponsor's protocol ID
- PALANGI-0601
- Other IDs
- 2006-003074-10
- Acronym
- PALANGI
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2007
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
- ClinicalTrials.gov ID
- NCT00420563
- Acronym / sponsor ID
- PALANGI / PALANGI-0601
- Conditions
- Cancer
- Keywords
- Cancer, palliative treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 25 Sep 2009 (actual)
- Primary completion
- 19 Jan 2011 (actual)
- Study completion
- 19 Jan 2011 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The scope of the trial is to assess the free progression rate at 2 months for each group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYCLOPHOSPHAMIDE | Experimental | Drug: CYCLOPHOSPHAMIDE |
| MEGESTROL | Active comparator | Drug: MEGESTROL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > or = 18
- PS-WHO < or = 1
- Histologically proven cancer
- No other therapeutic proposal
- Treatment can be orally taken
Key exclusion criteria (9 listed)
- Hypercalcemia ( Ca > 2.65 mmol/l)
- Breast cancer
- Thrombosis or pulmonary embolism
- Dysphagia, malabsorption
- Polynuclear neutrophil leukocytes < 1000/mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYCLOPHOSPHAMIDE50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision | Drug | CYCLOPHOSPHAMIDE |
| MEGESTROL320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision | Drug | MEGESTROL |
Primary outcome
Progression free survival rate at 2 months
Time frame: 2 months
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PENEL Nicolas, MD principal investigator
Centre Oscar Lambret
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYCLOPHOSPHAMIDE and MEGESTROL in people with Cancer, run by Centre Oscar Lambret at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival rate at 2 months (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.