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

NCT02767557 | Completed Phase 2 DMC

• 1 other identifier: GI1612
• Study Type: interventional
• Target: 147
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a multicenter center, 2-arms prospective randomized phase II trial which evaluates whether tocilizumab with gemcitabine/nab-paclitaxel is more effective than gemcitabine/nab-paclitaxel.

Conditions

Unresectable Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival at 6 months

  Approximately up to 6 months.

Secondary Outcomes (8)

• Performance status at 3 and 6 months assessed by investigator

  Approximately up to 6 months.

• Performance status at 3 and 6 months, assessed by patient

  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

  Randomization to disease progression, or death due to any cause if sooner. Approximately up to 6 months.

• Overall survival (OS), defined as the time from the date of randomization until death due to any cause.

  Randomization until death due to any cause. Approximately up to 12 months.

• Overall response rate (ORR) (ORR = CR + PR), according to RECIST 1.1.RECIST 1.1

  Approximately up to 6 months.

Study Arms (2)

Tocilizumab & Gemcitabine and nab-Paclitaxel

EXPERIMENTAL

Tocilizumab: 8 mg/kg given I. V. on day 1 over 60 minutes every 28 day cycle. Gemcitabine: 1000 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle. Nab-Paclitaxel: 125 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle.

Drug: Tocilizumab; Drug: Gemcitabine; Drug: nab-Paclitaxel

Gemcitabine and nab-Paclitaxel

ACTIVE COMPARATOR

Gemcitabine: 1000 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle. Nab-Paclitaxel: 125 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle.

Drug: Gemcitabine; Drug: nab-Paclitaxel

Interventions

Tocilizumab DRUG

Intravenous infusion

Also known as: (ACTEMRA®)

Tocilizumab & Gemcitabine and nab-Paclitaxel

Gemcitabine DRUG

Intravenous infusion

Gemcitabine and nab-Paclitaxel; Tocilizumab & Gemcitabine and nab-Paclitaxel

nab-Paclitaxel DRUG

Intravenous infusion,

Also known as: ABRAXANE®

Gemcitabine and nab-Paclitaxel; Tocilizumab & Gemcitabine and nab-Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 10⁹/L
• Platelet count ≥ 100 x 10⁹/L

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Herlev Hospital: lead
• Celgene: collaborator

Study Sites (2)

Herlev & Gentofte University Hospital, Denmark

Herlev, 2730, Denmark

Location

Department of Oncology

Oslo, 0424, Norway

Location

Related Publications (1)

• Chen IM, Johansen JS, Theile S, Silverman LM, Pelz KR, Madsen K, Dajani O, Lim KZM, Lorentzen T, Gaafer O, Koniaris LG, Ferreira AC, Neelon B, Guttridge DC, Ostrowski MC, Zimmers TA, Nielsen D. Randomized Phase II Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab as First-Line Treatment in Advanced Pancreatic Cancer: Survival and Cachexia. J Clin Oncol. 2025 Jun 20;43(18):2107-2118. doi: 10.1200/JCO.23.01965. Epub 2025 May 12.

  PMID: 40354592 DERIVED

MeSH Terms

Interventions

tocilizumab; Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Inna Chen, MD

  Herlev & Gentofte Hospital

  PRINCIPAL INVESTIGATOR

• Olav Dajani, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Specialist

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 10, 2016
• Study Start: January 26, 2017
• Primary Completion: August 12, 2021
• Study Completion: January 1, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

NO (1); DK (1)