Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer

NCT05841420 | Recruiting Phase 2 DMC

• 1 other identifier: DPCG-01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the efficacy and toxicity of full-dose Gemcitabine and reduced-dose combination chemotherapy in patients with non-resectable pancreatic cancer, who are unfit for full-dose combination chemotherapy. The patients will be equally randomized to arm A or arm B: Arm A: Full-dose single agent treatment with Gemcitabine 1000 mg/m2 weekly on days 1, 8,and 15 every 4 weeks. Arm B: Reduced-dose (80%) combination-treatment with Gemcitabine plus Nab-Paclitaxel (Gemcitabine: 800 mg/m2 plus Nab-Paclitaxel: 100 mg/m2 on day 1, 8 and 15 every 4 weeks) Progression-free survival, overall survival and response rate will be estimated for each group, as well as toxicity and quality of life will be prospectively registered.

Conditions

Pancreas Cancer; Non-Resectable Pancreas Carcinoma

Keywords

Fragile; Elderly; Palliative

Outcome Measures

Primary Outcomes (1)

• PFS (Progression Free Survival)

  PFS is defined in the ITT population as the date of the randomization to the date of disease progression or date of death, whichever comes first. The date of PD is the date of scan, if progression is found on a CT scan, or date of visit at which clinical progression is found. PD at CT is defined according to RECIST version 1.1.

  1 year from end of study accrual.

Secondary Outcomes (5)

• OS (Overall Survival)

  1 year from end of study accrual.

• RR (Response rate)

  1 year from end of study accrual.

• Hospitalizations

  Through study completion, an average of 6 months.

• Quality of Life (QOL) assessed by EORTC QLQ-C30 at baseline and after 8, 16, and 24weeks

  At baseline and at 8, 16, and 24 weeks.

• Cumulative worst toxicity during treatment

  From date of first treatment until 1 year from end of study treatment.

Study Arms (2)

A: "Full dose single agent strategy"

ACTIVE COMPARATOR

Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks

Drug: Gemcitabine

B: "Reduced dose (80%) combination-therapy strategy"

EXPERIMENTAL

Nab-Paclitaxel: 100mg/m2 plus gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks

Drug: Gemcitabine; Drug: Nab paclitaxel

Interventions

Gemcitabine DRUG

Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks or gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks

Also known as: Gemzar

A: "Full dose single agent strategy"; B: "Reduced dose (80%) combination-therapy strategy"

Nab paclitaxel DRUG

Nab-Paclitaxel: 100mg/m2 on day 1, 8 and 15 every 4 weeks

Also known as: Abraxane

B: "Reduced dose (80%) combination-therapy strategy"

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Adenocarcinoma of the pancreas, histopathologically or cytologically verified
• Non-resectable (locally advanced or metastatic) PC
• Patients unfit or not candidate for full-dose combination chemotherapy
• Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy
• Performance status (PS) ≤2
• Measurable or non-measurable disease
• Adequate hematologic function defined as absolute neutrophil count (ANC) ≥1.5 x 10\^9/l and platelets count ≥100x10\^9/l within 2 weeks prior to enrollment
• Adequate organ function (bilirubin ≤1.5 x UNL (Upper Normal Limit) and eGFR (estimated Glomerular Filtration Rate) \>50ml/min within 2 weeks prior to enrollment
• Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE \<grade 2
• Oral and written informed consent must be obtained according to the local Ethics committee requirements
• Fertile patients must use adequate contraceptives

You may not qualify if:

• Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation
• Prior chemotherapy for PC (However, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible)
• Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma
• Concurrent treatment with any other anti-cancer therapy
• Pregnant or breast-feeding patients
• Patients clearly intending to withdraw from the study if not randomized in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar, or geographic reasons.
• Other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
• Known allergy or intolerance to any of the drugs used in DPCG-01 (Gemcitabine, S1 or Nab-Paclitaxel)

Sponsors & Collaborators

• Morten Ladekarl: lead
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Herlev and Gentofte Hospital: collaborator
• Gødstrup Hospital: collaborator
• Vejle Hospital: collaborator

Study Sites (1)

Department of Oncology, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Related Publications (1)

• Rasmussen LS, Winther SB, Chen IM, Weber B, Ventzel L, Liposits G, Johansen JS, Detlefsen S, Egendal I, Shim S, Christensen S, Pfeiffer P, Ladekarl M. A randomized phase II study of full dose gemcitabine versus reduced dose gemcitabine and nab-paclitaxel in vulnerable patients with non-resectable pancreatic cancer (DPCG-01). BMC Cancer. 2023 Jun 16;23(1):552. doi: 10.1186/s12885-023-11035-6.

  PMID: 37328835 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Taxes; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Morten Ladekarl, Professor

  Aalborg Universitets Hospital, Department of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten Ladekarl, Professor

CONTACT

0045+61399326; morten.ladekarl@rn.dk

Louise Rasmussen, PhD

CONTACT

0045+30226432; loskr@rn.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, Phd

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 3, 2023
• Study Start: June 12, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)