Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab in Pancreatic Cancer Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2023
• Main ID: NCT02767557
• Date of registration: 06/05/2016
• Prospective Registration: Yes
• Primary sponsor: Herlev Hospital
• Public title: Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab in Pancreatic Cancer Patients PACTO
• Scientific title: A Multinational, Randomized, Phase II Study of the Combination of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab, an IL-6R Inhibitor, as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Cancer.
• Date of first enrolment: January 26, 2017
• Target sample size: 147
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02767557
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Denmark, Norway

Contacts

• Name: Inna Chen, MD
• Affiliation: Herlev & Gentofte Hospital

• Name: Olav Dajani, MD PhD
• Affiliation: Oslo University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent

- Histological or cytological pancreatic adenocarcinoma. Malignant unspecified tumor
cells in cytological specimen are allowed after investigator assessment, mixed
histology including adenosquamous carcinoma is allowed

- Male or non-pregnant, non-lactating females who are =18 years of age at the time of
signing the informed consent form (ICF)

- Non-curable unresectable locally advanced or metastatic pancreatic carcinoma.

- A modified Glasgow Prognostic Score (mGPS) criteria of 1 or 2 assessed within 14 days
of randomization as defined below:

- mGPS of 1: CRP > 10 mg/L and albumin = 35 g/L

- mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L

- No prior antineoplastic chemotherapy or anti-cancer drugs. Patients who have received
neoadjuvant or adjuvant chemotherapy and who are diagnosed with loco regional
recurrent or metastatic disease are not eligible

- ECOG/WHO Performance Status (PS) 0-1

- = 4 weeks since prior major surgery, = 2 weeks since prior minor surgery and = 1 week
since prior radiation therapy

- Measurable disease using the RECIST1.1 criteria, defined as lesions that can be
measured in at least one dimension and which have not been previously irradiated.
Longest diameter = 20 mm with conventional techniques or = 10 mm with spiral CT scan
or MRI

- Fertile men and women of childbearing potential (defined as a sexually mature woman
who (1) has not undergone hysterectomy [the surgical removal of the uterus] or
bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been
naturally postmenopausal for at least 24 consecutive months [ie, has had menses at any
time during the preceding 24 consecutive months]) must use secure contraception
methods as follows: intrauterine device, double-barrier contraception, as a condom and
occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent
(foam/gel/cream/suppository), vasectomized partner who is sterile prior to the female
subject's entry and is the sole sexual partner for that female, or complete abstinence
from sexual intercourse from before 2 months entering the study until 6 months after
end of chemotherapy

- Acceptable hematology parameters defined as:

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

- Platelet count = 100 x 10?/L

- Haemoglobin = 5.6 mmol/L

- Acceptable liver function defined as:

- Serum bilirubin < 1.5 x upper limit of normal (ULN)

- ASAT/ALAT < 2.5 x ULN ( < 5 x ULN with known liver metastasis)

- Acceptable renal function with a creatinine clearance = 50 mL/min/ (eg, using the
Cockroft-Gault formula)

- Subjects must have signed and dated a BIOPAC IRB/IEC approved written informed consent
form in accordance with regulatory and institutional guidelines. This must be obtained
before the performance of any protocol related procedures that are not part of normal
subject care

Exclusion Criteria:

- Electrocardiogram (ECG) with significant modifications suggesting a high risk of
occurrence of angina pectoris or high risk of arrhythmia.

- Other malignancies, except adequately treated basal carcinoma or squamous cell
carcinoma of the skin or in-situ cervix carcinoma or incidental prostate cancer (T1a,
Gleason score = 6, PSA < 0.5 ng/ml), or any other tumor with a disease free survival
of = 5 years.

- History of serious or concurrent illness or uncontrolled medical disorder; any medical
condition that might be aggravated by chemotherapy treatment or which could not be
controlled; including, but not restricted to:

- Active infection requiring antibiotics within 2 weeks before the study inclusion

- Concurrent congestive heart failure NYHA ( class III - IV )

- Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly
controlled hypertension

- Inflammatory bowel disease (colitis, Crohns) or other serious gastrointestinal
conditions associated with risk of perforation

- Peripheral neuropathy grade = 2 according to CTCAE v 4.0

- Concomitant use of immunosuppressive or myelosuppressive medications that would in the
opinion of the investigator, increase the risk of serious neutropenic complications.

- No known or suspected allergy to the investigational agents or any agents given in
association with this trial.

- Pregnant or lactating women.

- Any psychological, familial, sociological, or geographical condition which does not
permit protocol compliance and medical follow-up.

- Enrollment in any other clinical protocol or investigational study with an
interventional agent or assessments that may interfere with study procedures.



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

Health Condition(s) or Problem(s) studied

Unresectable Pancreatic Carcinoma

Intervention(s)

Drug: Tocilizumab

Drug: nab-Paclitaxel

Drug: Gemcitabine

Primary Outcome(s)

Overall survival at 6 months [Time Frame: Approximately up to 6 months.]

Secondary Outcome(s)

Safety (Data on safety parameters) Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments. [Time Frame: Approximately up to 6 months.]

Disease control rate (DCR), (DCR = CR + PR + SD), according to RECIST 1.1. [Time Frame: Approximately up to 6 months.]

Overall survival (OS), defined as the time from the date of randomization until death due to any cause. [Time Frame: Randomization until death due to any cause. Approximately up to 12 months.]

Performance status at 3 and 6 months assessed by investigator [Time Frame: Approximately up to 6 months.]

Quality of Life (Quality of Life Questionnaire C30 (QLQ-C30) Version 3.0). [Time Frame: Approximately up to 6 months.]

Progression free survival (PFS), defined as the time from the date of randomization until the earliest date of disease progression [Time Frame: Randomization to disease progression, or death due to any cause if sooner. Approximately up to 6 months.]

Overall response rate (ORR) (ORR = CR + PR), according to RECIST 1.1.RECIST 1.1 [Time Frame: Approximately up to 6 months.]

Performance status at 3 and 6 months, assessed by patient [Time Frame: Approximately up to 6 months.]

Secondary ID(s)

GI1612

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celgene