Öffentliches Studienregister des CCC-München

Studie ALPACA

Studie Studiendesign Status Ein-/Auschlusskriterien Therapie Teilnehmer Dokumente Berechtigungen Tumorboards

Studie
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Studienakronym
:
ALPACA
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Vollständiger Titel
:

Induction treatment with nab-paclitaxel/gemcitabine for first-line treatment of metastatic pancreatic cancer followed by either alternating application of gemcitabine monotherapy and nab-paclitaxel/gemcitabine or continuing application of nab-paclitaxel/gemcitabine: A randomized phase II study

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EudraCT-Nr.
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Zuständige Einrichtung
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Lmu
Krankheitsentitäten
Klassifikation Code Beschreibung
ICD-10-GM C25.- Bösartige Neubildung des Pankreas
Studiendesign
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Studientyp
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Interventionsstudie
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Verblindungstyp
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Offen
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Studienphase
:
II
Status
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Status
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Rekrutierung aktiv
Voten
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Ethikkommission - Votum
:
Positiv
Initiierung & Abschluß
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Abschlussdatum (Plan / Ist)
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Unbekannt / Unbekannt
Therapie
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Therapie
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3 cycles nab-paclitaxel/gemcitabine; duration of each cycle 28 days
Nab-paclitaxel 125 mg/m2, IV infusion over 30 minutes, followed by gemcitabine
1000 mg/m2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle
Patient with progression or unacceptable toxicity have to discontinue study
treatment.
After three cycles nab-paclitaxel/gemcitabine tumor evaluation is performed.
Randomization in Arm A and Arm B will take place for all patients with at least
stable disease (SD).
Continuous treatment after randomization
Standard Arm A
Patients randomized in Arm A will receive continuing application of nabpaclitaxel/
gemcitabine treatment cycles until progression or unacceptable toxicity.
Duration of each cycle is 28 days and comprises:
Nab-paclitaxel 125 mg/m2, IV infusion over 30 minutes, followed by gemcitabine
1000 mg/m2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle
Experimental Arm B
Patients randomized in Arm B will receive alternating application of gemcitabine
monotherapy and nab-paclitaxel/gemcitabine treatment cycles until progression
or unacceptable toxicity, starting with a treatment cycle of gemcitabine. Duration of
each cycle irrespective of treatment cycle with gemcitabine or with nabpaclitaxel/
gemcitabine is 28 days.
Gemcitabine treatment cycle:
Gemcitabine 1000 mg/m2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day
cycle
Nab-paclitaxel/gemcitabine treatment cycle:
Nab-paclitaxel 125 mg/m2, IV infusion over 30 minutes, followed by gemcitabine
1000 mg/m2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle
At discontinuation of study treatment (standard or experimental arm) due to
progression patients with a good performance status are encouraged to receive a nonneurotoxic
combination of a fluoropyrimidine. In the presence of a reduced
performance status treatment with a mono fluoropyrimidine may be recommended.
However, this further second-line treatment is not part of the study protocol and at
investigator’s discretion.

Teilnehmer Die Studienleitung hat einer Freigabe der Kontaktdaten der Hauptprüfer bzw. Hauptansprechpartner nicht explizit zugestimmt.