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CancerPhase 1PAL-ANGI2NCT01374620

Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel

A Phase 1 study testing Paclitaxel dose escalation, Paclitaxel and Cyclophosphamide in people with Cancer, run by Centre Oscar Lambret at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cancer
What is being tested?
Paclitaxel dose escalation, Paclitaxel and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteFrance
Study dates
13 Jul 2011to Apr 2013
Phase
Phase 1
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with cancer histologically proved
  • No other therapeutic proposal after discussion in multidisciplinary consultation
  • Radiological evidence of the evolving nature of the disease
  • Measurable disease with at least one measurable lesion according to the criteria RECIST 1.1
  • At least 28 days since prior treatment(systemic treatment or major surgery)
  • Patient who have recovered from any previous toxicity
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  • Man or woman de ≥ 18 years and ≤ 65 years
  • Performance Status (ECOG) ≤ 2 within 7 days before inclusion
  • Polynuclear neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3, Hemoglobin ≥ 9 g/dl
  • Serum Albumin ≥ 36 g/l and lymphocytes ≥ 700/mm3
  • Total bilirubin and SGPT/ALT and SGOT/AST ≤ 3 ULN(≤ 5 ULN if liver metastases)
  • Creatinine in normal ranges and Creatinine clearance > 60 ml/min (Cockcroft formulae)
  • Central venous access
  • Negative pregnancy test for women who may be pregnant within 7 days before inclusion
  • Effective contraceptive during the treatment period and up to 6 months after the end of treatment (for patients of both sexes during their reproductive and child-bearing age and their partners)
  • Patient covered by government health insurance
  • Informed consent signed by the patient before any specific study procedure

Who cannot join

  • Prior treatment by Paclitaxel
  • Oral treatment impossible
  • Known dysphagia, malabsorption or maldigestion
  • Pre-existing neuropathy clinically symptomatic
  • Known leptomeningeal brain metastases
  • Known allergy to Cremophor, to Paclitaxel or one of its excipients (especially polyoxyethylene castor oil), to Cyclophosphamide or one of its excipients (lactose, sucrose)
Show all 14Show fewer
  • Active and uncontrolled infection
  • Acute urinary tract infection, pre-existing hemorrhagic cystitis
  • Diabetes insipidus
  • History or progressive psychiatric illness
  • Persons under guardianship or detainees
  • Unable for medical follow-up (geographic, social or mental reasons)
  • Pregnant, or likely to be or breastfeeding women
  • Absence of effective contraception for the duration of treatment and 6 months after completion of therapy (for patients of both sexes in childbearing or reproductive age and their partners)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Oscar Lambret

    Lille, 59000

Other trials in France

About this study

Official title: Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide

The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.

Read the detailed description

The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide for cancer which present no therapeutic solution

Conditions
Cancer
Being tested
Paclitaxel dose escalation, Paclitaxel, Cyclophosphamide, Blood collection
Keywords
Cancer
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel dose escalationDrug

    Also called Taxol

    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:

    • 40
    • 60
    • 70
    • 75
    • 80
    • 85
    • 90

  • PaclitaxelDrug

    Also called Taxol

    Patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose in association with metronomic cyclophosphamide

  • CyclophosphamideDrug

    Also called Endoxan

    D1 to D28: 50 mg x 2/day/cycle

    1 cycle = 28 days

  • Blood collectionBiological

    At D1, D8, D15 and D21 of cycle 1 and cycle 2:2 blood samples for the correlation between clinical response and biological parameters

Study groups in NCT01374620
Study groupRoleWhat they receive
Paclitaxel Dose escalationExperimentalA 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
Receives: Drug: Paclitaxel dose escalation; Drug: Cyclophosphamide; Biological: Blood collection
Cohort extensionExperimentalAn additional 10 patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose + blood collection
Receives: Drug: Paclitaxel; Drug: Cyclophosphamide; Biological: Blood collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    • Polynuclear neutrophils < 500/mm3 for more than 7 days
    • Febrile neutropenia (Polynuclear neutrophils < 1 000/mm3 and fever > or = 38.5°C) or documented infection
    • Thrombopenia (Platelets < 25 000/mm3)
    • Impossibility to administer D8 or D15 due to hematological criteria

    Non-hematological toxicity:

    Any grade 3 or 4 toxicity related to study treatment, with the exception of fatigue and alopecia

    Measured: 28 days = cycle 1

Secondary outcomes (6)

  1. Description of the nature of adverse events

    According to the NCI-CTCAE scale v4.0

    Measured: During the study treatment, an expected average of 2 months

  2. Evaluation of objective response after 2 cycles

    Objective response (complete response, partial response and stable disease) according to RECIST 1.1 criteria

    Measured: After 2 cycles = 2 months

  3. Estimation of the free-progression median time

    Time between the inclusion and the disease progression (clinical or radiological)

    Measured: Until disease progression

  4. Calculation of the Growth Modulation Index (GMI)

    Time to progression on study treatment and time to progression on prior treatment

    Measured: Until disease progression

  5. Evaluation of the correlation between clinical response and biological parameters

    Biological parameters related to angiogenesis

    Measured: Day 1, 8, 15, 21 of cycle 1 and cycle 2

  6. Description of the severity of adverse events

    According to the NCI-CTCAE scale v4.0

    Measured: During the study treatment, an expected average of 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2011 (estimated)
  2. Study start13 Jul 2011
  3. Primary completionFeb 2013
  4. Study completionApr 2013

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01374620
Sponsor's protocol ID
PAL-ANGI2-1101
Other IDs
2011-001155-36
Acronym
PAL-ANGI2
Status last verified
Mar 2026
First submitted
14 Jun 2011
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 30064401

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel dose escalation, Paclitaxel and Cyclophosphamide in people with Cancer, run by Centre Oscar Lambret at 1 site 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 17 inclusion and 14 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Determination of the iv paclitaxel maximum tolerated dose and recommended dose in association with a fixed dose of oral cyclophosphamide (time frame: 28 days = cycle 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01374620, which also lists 1 linked publication.

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 16 Mar 2026.

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