Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients

NCT02812992 | Completed Phase 4

• 1 other identifier: AIO-GER-0115
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The GrantPax study is a multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/- nab-paclitaxel in elderly pancreatic cancer patients. The primary objective is that CGA-stratified patients do not decline in their CGA performance in response to chemotherapy measured as a loss of five points or less in the Barthel's ADL, (ADL1 vs. ADL2 during core CGA assessment).

Conditions

Adenocarcinoma Pancreas

Outcome Measures

Primary Outcomes (1)

• Barthel's ADL [Barthel's scale in activities of daily living]

  Loss of five points or less in the Activity of Daily Living (Barthel's ADL; assessed during 2nd CGA) after first cycle of chemotherapy (or after 4 weeks in BSC group) compared to the initial ADL for each treatment groups.

  4 weeks

Secondary Outcomes (18)

• CGA [Comprehensive Geriatric Assessment]

  4 weeks

• ECOG [Eastern Cooperative Oncology Group]

  4 weeks

• ADL (Barthel) [Activities of Daily Living]

  4 weeks

• IADL (Lawton/Browdy) [Instrumental Activities of Daily Living]

  4 weeks

• G8-Questionnaire

  4 weeks

Study Arms (3)

GO-GO arm

ACTIVE COMPARATOR

Nab-paclitaxel 125 mg/m\^2 i.v. over 30 minutes followed by gemcitabine infusion 1000 mg/m\^2 on days D1, D8, D15 of a 28-day cycle.

Drug: Nab-paclitaxel; Drug: Gemcitabine

SLOW-GO arm

ACTIVE COMPARATOR

Gemcitabine 1000 mg/m\^2 i.v. on days D1, D8, D15 of a 28-day cycle.

Drug: Gemcitabine

FRAIL arm

ACTIVE COMPARATOR

Best supportive care as determined by the investigator.

Other: Best Supportive Care

Interventions

Nab-paclitaxel DRUG

Also known as: Abraxane®

GO-GO arm

Gemcitabine DRUG

GO-GO arm; SLOW-GO arm

Best Supportive Care OTHER

FRAIL arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients ≥ 70 years of age.
• Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
• At least one measurable lesion of disease according to RECIST 1.1 criteria.
• No prior chemotherapy (except fluoruracil or gemcitabine in an adjuvant setting at least \> 6 months prior enrollment).
• Adequate end organ function:
• renal function: serum creatinine ≤ 1.5 x ULN or GFR ≥ 30mL/min.
• hematopoietic function: white blood cell (WBC) count ≥3000/μL, absolute neutrophil count (ANC) ≥ 1500/μL, platelets ≥10\^5/μL, hemoglobin level \>9.0 g/dL
• liver function: total bilirubin ≤1.5 x ULN, AST / ALT ≤3.0 x ULN
• Cooperation and willingness to complete all aspects of the study
• Written informed consent to participate in the study
• Patients ≥ 70 years of age.
• Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
• No prior chemotherapy (except fluoruracil or gemcitabine in an adjuvant setting at least \> 6 months prior enrollment).
• Cooperation and willingness to complete all aspects of the study
• Written informed consent to participate in the study

You may not qualify if:

• Patients \<70 years of age.
• Papillary cancer, cholangiocellular carcinoma, neuro-endocrine tumors.
• Patient has a severe and/or uncontrolled medical disease (i.e. uncontrolled active infection, uncontrolled hypertension/ diabetes or cardiac disease).
• Patient has received any other investigational product within 28 days prior study entry.
• Patient is \< 5 years free of another primary malignancy (except: not currently clinically significant nor requiring active intervention)
• Hypersensitivity against gemcitabine or nab-paclitaxel.
• Major surgery ≤ 28 days prior to study entry.
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
• Any other chemotherapy at start.
• Any psychiatric illness that would affect the patient's ability to understand the demands of the clinical trial.
• Parallel participation in another clinical trial or participation in another clinical trial within the last 30 days or 7 half-lifes of a study medication, whichever is of longer duration, prior study start.
• Patient has already been recruited in this trial.
• Patients who do not understand the nature, the scope and the consequences of the clinical trial.
• Patient who might be dependent on the sponsor, the study site or the investigator.

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead

Study Sites (1)

Universitätsklinikum Mannheim II. Medizinische Klinik

Mannheim, 68167, Germany

Location

Related Publications (1)

• Betge J, Chi-Kern J, Schulte N, Belle S, Gutting T, Burgermeister E, Jesenofsky R, Maenz M, Wedding U, Ebert MP, Haertel N. A multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/- nab-paclitaxel in elderly pancreatic cancer patients (GrantPax). BMC Cancer. 2018 Jul 18;18(1):747. doi: 10.1186/s12885-018-4665-2.

  PMID: 30021548 DERIVED

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Matthias Ebert, Prof.

  Universitätsklinikum II. Medizinische Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 24, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)