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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05841420
Recruitment Status : Recruiting
First Posted : May 3, 2023
Last Update Posted : July 27, 2023
Sponsor:
Collaborators:
Aarhus University Hospital
Odense University Hospital
Herlev and Gentofte Hospital
Gødstrup Hospital
Vejle Hospital
Information provided by (Responsible Party):
Morten Ladekarl, Aalborg University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pancreas Cancer Non-Resectable Pancreas Carcinoma Drug: Gemcitabine Drug: Nab paclitaxel Phase 2

Detailed Description:

According to guidelines the recommended treatment for patients with non-resectable pancreatic cancer (PC) is combination chemotherapy, whereas old and/or fragile patients can be offered Gemcitabine monotherapy, if they are fit for treatment. Phase III trials show improved effect of combination chemotherapy compared to Gemcitabine, but these trials were restricted to fit patients younger than 75 years of age, as full-dose combination chemotherapy is more toxic.

Studies in colorectal cancer and a post-hoc analysis of Gemcitabine plus Nab-Paclitaxel in PC suggest that reduced-dose of combination chemotherapy may be more efficient in terms of progression-free survival and less toxic as compared to monotherapy in elderly and/or frail patients, but reduced start-dosing of GemNab is not currently labelled.

Moreover, a recent Danish register-based study showed that more use of combination chemotherapy at oncological departments was associated with improved outcome of patients with PC.

Elderly and frail patients with PC are in great need of better treatment results. Hence, a comparative study of reduced-dose combination chemotherapy is warranted and may be practice changing.

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 PC, who are unfit for full-dose combination chemotherapy.

The study is a national multicenter prospective randomized phase II trial, endorsed by the Danish Pancreas Cancer Group (DPCG). 98 patients with non-resectable PC, unfit for full-dose combination chemotherapy, but eligible for first-line chemotherapy, will be included.

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 GemNab (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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients With Non-resectable Pancreatic Cancer
Actual Study Start Date : June 12, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A: "Full dose single agent strategy"
Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks
 Drug: Gemcitabine
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
Other Name: Gemzar
Experimental: B: "Reduced dose (80%) combination-therapy strategy"
Nab-Paclitaxel: 100mg/m2 plus gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks
 Drug: Gemcitabine
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
Other Name: Gemzar

Drug: Nab paclitaxel
Nab-Paclitaxel: 100mg/m2 on day 1, 8 and 15 every 4 weeks
Other Name: Abraxane


Outcome Measures
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Primary Outcome Measures :
  1. PFS (Progression Free Survival) [ Time Frame: 1 year from end of study accrual. ]
    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.


Secondary Outcome Measures :
  1. OS (Overall Survival) [ Time Frame: 1 year from end of study accrual. ]
    OS is defined in the ITT population as the date of randomization to date of death of all causes.

  2. RR (Response rate) [ Time Frame: 1 year from end of study accrual. ]
    In patients with measurable disease at baseline, RECIST version 1.1 will be used for evaluation of complete response (CR), partial response (PR), stable disease (SD) or PD. ORR will be calculated as the percentage of patients with CR+PR of all patients with measurable disease, who received at least one treatment and were evaluated by at least one diagnostic CT scan.

  3. Hospitalizations [ Time Frame: Through study completion, an average of 6 months. ]
    The total number of hospital admissions in a stationary unit with overnight stay from the start of treatment to the date of end of treatment will be assessed in the treated population. If the patient is readmitted for the same reason within 3 days (e.g., after weekend leave), this is not counted as a separate admission. The reasons for admission are registered as toxicity due to treatment or symptoms due to PC. The sum of hospitalizations is calculated for each randomization arm for comparison.

  4. Quality of Life (QOL) assessed by EORTC QLQ-C30 at baseline and after 8, 16, and 24weeks [ Time Frame: At baseline and at 8, 16, and 24 weeks. ]
    QoL scores collected will be linearly transformed to a scale of 0 to 100. Items will be grouped in health status scale (range 0 - 100, high is better), functional scales (range 0 - 100, high is better) and symptom scales (range 0 - 100, low is better). Each scale is summarized by its mean, and standard deviation for the patients in the two treatment groups. The difference in mean at 8, 16 and 24 weeks are compared with the baseline mean within in each treatment groups. The difference in mean between the treatment groups are compared at baseline, 8, 16 and 12 weeks.

  5. Cumulative worst toxicity during treatment [ Time Frame: From date of first treatment until 1 year from end of study treatment. ]
    (Adverse events ≥ grade 3 according to CTCAE version 5.0). All patients who have received 1 dose of chemotherapy will be calculated in the safety analyses. Cumulative worst toxicities ≥CTC grade 3 in the treated population are registered for each arm separately for comparison.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05841420


Contacts
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Contact: Morten Ladekarl, Professor 0045+61399326 morten.ladekarl@rn.dk
Contact: Louise Rasmussen, PhD 0045+30226432 loskr@rn.dk

Locations
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Denmark
Department of Oncology, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Morten Ladekarl, MD, DMSci    +45 97660545    morten.ladekarl@rn.dk   
Contact: Anja Pagh, MD, PhD    +45 97661417    a.pagh@rn.dk   
Sponsors and Collaborators
Morten Ladekarl
Aarhus University Hospital
Odense University Hospital
Herlev and Gentofte Hospital
Gødstrup Hospital
Vejle Hospital
Investigators
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Principal Investigator: Morten Ladekarl, Professor Aalborg Universitets Hospital, Department of Oncology
More Information
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Responsible Party: Morten Ladekarl, Professor, MD, Phd, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT05841420    
Other Study ID Numbers: DPCG-01
First Posted: May 3, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Morten Ladekarl, Aalborg University Hospital:
Fragile
Elderly
Palliative
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
 Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites