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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001155-36 | EudraCT Number |
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The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.
The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide for cancer which present no therapeutic solution
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel Dose escalation | Experimental | A standard dose escalation strategy will be used including 3 to 6 patients at each dose level (Paclitaxel dose escalation + fixed dose of cyclophosphamide) + blood collection |
|
| Cohort extension | Experimental | An additional 10 patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose + blood collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel dose escalation | Drug | Paclitaxel will be administered intravenously over 60 minutes, at D1, D8 and D15, at a given dose. The Paclitaxel dose (mg/infusion) levels are as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the iv paclitaxel maximum tolerated dose and recommended dose in association with a fixed dose of oral cyclophosphamide | A DLT is defined below: Hematological toxicity:
Non-hematological toxicity: Any grade 3 or 4 toxicity related to study treatment, with the exception of fatigue and alopecia | 28 days = cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the nature of adverse events | According to the NCI-CTCAE scale v4.0 | During the study treatment, an expected average of 2 months |
| Evaluation of objective response after 2 cycles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas PENEL, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | 59000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30064401 | Derived | Pannier D, Adenis A, Bogart E, Dansin E, Clisant-Delaine S, Decoupigny E, Lesoin A, Amela E, Ducornet S, Meurant JP, Le Deley MC, Penel N. Once weekly paclitaxel associated with a fixed dose of oral metronomic cyclophosphamide: a dose-finding phase 1 trial. BMC Cancer. 2018 Jul 31;18(1):775. doi: 10.1186/s12885-018-4678-x. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D003520 | Cyclophosphamide |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Paclitaxel | Drug | Patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose in association with metronomic cyclophosphamide |
|
|
| Cyclophosphamide | Drug | D1 to D28: 50 mg x 2/day/cycle 1 cycle = 28 days |
|
|
| Blood collection | Biological | At D1, D8, D15 and D21 of cycle 1 and cycle 2:2 blood samples for the correlation between clinical response and biological parameters |
|
Objective response (complete response, partial response and stable disease) according to RECIST 1.1 criteria
| After 2 cycles = 2 months |
| Estimation of the free-progression median time | Time between the inclusion and the disease progression (clinical or radiological) | Until disease progression |
| Calculation of the Growth Modulation Index (GMI) | Time to progression on study treatment and time to progression on prior treatment | Until disease progression |
| Evaluation of the correlation between clinical response and biological parameters | Biological parameters related to angiogenesis | Day 1, 8, 15, 21 of cycle 1 and cycle 2 |
| Description of the severity of adverse events | According to the NCI-CTCAE scale v4.0 | During the study treatment, an expected average of 2 months |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |