First-line Treatment of Metastatic Pancreatic Cancer With Nab-paclitaxel and Gemcitabine

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2022
• Main ID: NCT02564146
• Date of registration: 29/09/2015
• Prospective Registration: Yes
• Primary sponsor: AIO-Studien-gGmbH
• Public title: First-line Treatment of Metastatic Pancreatic Cancer With Nab-paclitaxel and Gemcitabine ALPACA
• Scientific title: 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
• Date of first enrolment: December 2016
• Target sample size: 325
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02564146
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Frank Kullmann, Prof. Dr.
• Affiliation: Kliniken Nordoberpfalz AG Klinikum Weiden Medizinische Kliniken I

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients (= 18 years of age)

- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
Patients with islet cell neoplasms are excluded.

- Karnofsky Perfomance Status (KPS) = 70%

- At least one unidimensionally measurable lesion as assessed by CT- scan or Magnetic
resonance imaging (MRI) according to Response Evaluation Criteria In Solid Tumors
(RECIST1.1 ),

- Total bilirubin = 1.5 x ULN (Upper Limit of Normal). Patients with a biliary stent may
be included provided that bilirubin level after stent insertion decreased to = 1.5 x
ULN and there is no cholangitis.

- Adequate renal, hepatic and bone marrow function, defined as

- Calculated creatinine clearance = 30 mL/min according to CKD-EPI formula (Chronic
kidney Disease Epidemiology Collaboration)

- AST/GOT and/or ALT/GPT = 2.5 x ULN and = 5.0 x ULN in case of liver metastasis

- Absolute neutrophil count (ANC) = 1.5 x 10^9/L

- Haemoglobin = 9 g/dL

- Platelets = 100 x 100 x 10^9/L

- Females of Childbearing Potential (FCBP) must have a negative serum pregnancy test
within 7 days of the first application of study treatment and they must agree to
undergo further pregnancy tests before randomization and at the end of treatment visit
and

- FCBP must either agree to use and be able to take effective contraceptive birth
control measures (Pearl Index < 1) or agree to practice complete abstinence from
heterosexual intercourse during the course of the study and for at least 1 month after
last application of study treatment. A female subject is considered to be of
childbearing potential unless she is age = 50 years and naturally amenorrhoeic for = 2
years, or unless she is surgically sterile.

- Males must agree not to father a child during the course of the trial and for at least
6 months after last administration of study drugs.

- Signed and dated informed consent before the start of any specific protocol procedures
Patient's legal capacity to consent to study participation

Exclusion Criteria:

- Missing histological or cytological confirmation of metastatic adenocarcinoma of the
pancreas Locally advanced pancreatic adenocarcinoma without metastases Any previous
radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of
metastatic disease. (Prior adjuvant chemotherapy with gemcitabine or fluoropyrimidine
in curative intent is allowed if terminated more than 6 months before first
application of study treatment. Previous palliative radiotherapy of bonemetastases for
alleviation of pain is permitted provided that irradiated bone metastases are no
target lesions.) Known brain metastase/brain metastases. Brain imaging is required in
symptomatic patients to rule out brain metastases, but is not required in asymptomatic
patients.

- Pre-existing peripheral neuropathy = grade 2 according to CTCAE version 4 (Common
Terminology Criteria for Adverse Events)

- • Medical history of interstitial lung disease (ILD) or pulmonary fibrosis

- Patients with high cardiovascular risk, including, but not limited to, recent coronary
stenting or myocardial infarction in the past year.

- Uncontrolled severe illness or medical condition (including uncontrolled diabetes
mellitus)

- Any other severe concomitant disease or disorder, which could influence patient's
ability to participate in the study and his/her safety during the study or interfere
with interpretation of study results e.g. severe hepatic, renal, pulmonary, metabolic,
or psychiatric disorders Previous or concurrent tumor other than underlying tumor
disease (pancreatic cancer) with the exception of cervical cancer in situ, adequately
treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial
bladder tumors (Ta, Tis, and T1) or any curatively treated tumors > 5 years prior to
enrolment Hypersensitivity against nab-paclitaxel, gemcitabine, or any excipients of
these drugs

- Continuing abuse of alcohol, drugs, or medical drugs

- Pregnant females, breast feeding females or females of childbearing potential unable
to perform adequate contraceptive measures or practice complete abstinence from
heterosexual intercourse

- Participation in any other clinical trial or treatment with any experimental drug
within 28 days before enrolment to the study or during study participation until the
end of treatment visit.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Adenocarcinoma of the Pancreas

Metastatic Pancreatic Cancer

Intervention(s)

Drug: gemcitabine mono and nab-paclitaxel and gemcitabine

Drug: nab-paclitaxel and gemcitabine

Primary Outcome(s)

Overall survival (OS) [Time Frame: After randomization until date of death or end of study wichever comes first. Assessed for up to 38.5 month]

Secondary Outcome(s)

Disease control rate (DCR) [Time Frame: Assessed for up to 42 month]

Overall survival (OS) [Time Frame: 3.5 month]

Quality of life QLQ-C30 [Time Frame: Assessed for up to 3.5 month]

Time of treatment without toxicity [Time Frame: Assessed for up to 3.5 month]

Adverse Events (AE) [Time Frame: Assessed for up to 11.5 month]

Progression-free survival (PFS) [Time Frame: Assessed for up to 42 month]

Neurotoxicity Assessment FACT taxane score [Time Frame: Assessed for up to 11.5 month]

Progression-free survival (PFS) [Time Frame: 3.5 month]

Disease control rate (DCR) [Time Frame: Assessed for up to 3.5 month]

Neurotoxicity Assessment FACT taxane score [Time Frame: Assessed for up to 3.5 month]

Adverse Events (AE) [Time Frame: Assessed for up to 3.5 month]

Overall response rate (ORR) [Time Frame: Assessed for up to 3.5 month]

Overall response rate (ORR) [Time Frame: Assessed for up to 42 month]

Overall survival (OS) [Time Frame: 42 month]

Progression-free survival (PFS) [Time Frame: Assessed for up to 38.5 month]

Quality of life QLQ-C30 [Time Frame: Assessed for up to 8 month]

Time of treatment without toxicity [Time Frame: Assessed for up to 11.5 month]

Secondary ID(s)

2014-004086-24

AIO-PAK-0114

AX-CL-PANC-AIO-004415

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ClinAssess GmbH

Celgene Corporation