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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812992
Recruitment Status : Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
AIO-Studien-gGmbH

Tracking Information
First Submitted Date  ICMJE June 7, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
Barthel's ADL [Barthel's scale in activities of daily living] [ Time Frame: 4 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • CGA [Comprehensive Geriatric Assessment] [ Time Frame: 4 weeks ]
    Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC
  • ECOG [Eastern Cooperative Oncology Group] [ Time Frame: 4 weeks ]
    Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC
  • ADL (Barthel) [Activities of Daily Living] [ Time Frame: 4 weeks ]
    Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC
  • IADL (Lawton/Browdy) [Instrumental Activities of Daily Living] [ Time Frame: 4 weeks ]
    Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC
  • G8-Questionnaire [ Time Frame: 4 weeks ]
    Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC
  • CR [Complete Response] [ Time Frame: 12 months ]
  • PR [Partial Response] [ Time Frame: 12 months ]
  • DCR [Disease Control Rate] [ Time Frame: 12 months ]
  • ORR [Objective Response Rate] [ Time Frame: 12 months ]
  • AEs/SAEs [Adverse Events/Serious Adverse Events] [ Time Frame: 12 months ]
  • PFS [Progression Free Survival] [ Time Frame: 12 months ]
  • OS [Overall Survival] [ Time Frame: 12 months ]
  • Percentage of patients receiving at least one chemotherapy in each treatment group [ Time Frame: 12 months ]
  • Percentage of patients escalating treatment [ Time Frame: 12 months ]
  • Duration of treatment [ Time Frame: 12 months ]
  • Cumulative dose [ Time Frame: 12 months ]
  • QoL [Quality of Life] [ Time Frame: 12 months ]
    time to QoL deterioration [loss of 10 points or more in QLQ-C30]
  • Discrepancy between CGA strata estimation by the investigator and true CGA assessment [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients
Official Title  ICMJE A Multicenter Phase 4 Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients
Brief Summary The hypothesis of the proposed study is that individualized assessment directed treatment algorithms identifies elderly patients, who benefit from combined nab-paclitaxel/gemcitabine therapy. The project uses a CGA, which includes various tests and scoring systems, to stratify patients as "GO-GO", "SLOW-GO" or "FRAIL" patients. Depending on test results patients receive chemotherapy (GO-GO group: nab-paclitaxel/gemcitabine; SLOW-GO group: gemcitabine monotherapy) or best supportive care (FRAIL group). After the first cycle of chemotherapy (4 weeks) a subsequent CGA and a safety assessment will be performed to assign patients to their definite treatment arm. 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).
Detailed Description The hypothesis of the proposed study is that individualized assessment directed treatment algorithms identifies elderly patients, who benefit from combined nab-paclitaxel/gemcitabine therapy. The project uses a CGA, which includes various tests and scoring systems, to stratify patients as "GO-GO", "SLOW-GO" or "FRAIL" patients. Depending on test results patients receive chemotherapy (GO-GO group: nab-paclitaxel/gemcitabine; SLOW-GO group: gemcitabine monotherapy) or best supportive care (FRAIL group). After the first cycle of chemotherapy (4 weeks) a subsequent CGA and a safety assessment will be performed to assign patients to their definite treatment arm. 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma Pancreas
Intervention  ICMJE
  • Drug: Nab-paclitaxel
    Other Name: Abraxane®
  • Drug: Gemcitabine
  • Other: Best Supportive Care
Study Arms  ICMJE
  • Active Comparator: GO-GO arm
    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.
    Interventions:
    • Drug: Nab-paclitaxel
    • Drug: Gemcitabine
  • Active Comparator: SLOW-GO arm
    Gemcitabine 1000 mg/m^2 i.v. on days D1, D8, D15 of a 28-day cycle.
    Intervention: Drug: Gemcitabine
  • Active Comparator: FRAIL arm
    Best supportive care as determined by the investigator.
    Intervention: Other: Best Supportive Care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2016)
135
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria 1 - Chemotherapy arms (Go-Go, Slow-Go):

  1. Patients ≥ 70 years of age.
  2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
  3. At least one measurable lesion of disease according to RECIST 1.1 criteria.
  4. No prior chemotherapy (except fluoruracil or gemcitabine in an adjuvant setting at least > 6 months prior enrollment).
  5. 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
  6. Cooperation and willingness to complete all aspects of the study
  7. Written informed consent to participate in the study

Inclusion criteria 2 - FRAIL arm:

  1. Patients ≥ 70 years of age.
  2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
  3. No prior chemotherapy (except fluoruracil or gemcitabine in an adjuvant setting at least > 6 months prior enrollment).
  4. Cooperation and willingness to complete all aspects of the study
  5. Written informed consent to participate in the study

Exclusion Criteria 1 - Chemotherapy arms (Go-Go, Slow-Go):

  1. Patients <70 years of age.
  2. Papillary cancer, cholangiocellular carcinoma, neuro-endocrine tumors.
  3. Patient has a severe and/or uncontrolled medical disease (i.e. uncontrolled active infection, uncontrolled hypertension/ diabetes or cardiac disease).
  4. Patient has received any other investigational product within 28 days prior study entry.
  5. Patient is < 5 years free of another primary malignancy (except: not currently clinically significant nor requiring active intervention)
  6. Hypersensitivity against gemcitabine or nab-paclitaxel.
  7. Major surgery ≤ 28 days prior to study entry.
  8. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
  9. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  10. Any other chemotherapy at start.
  11. Any psychiatric illness that would affect the patient's ability to understand the demands of the clinical trial.
  12. 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.
  13. Patient has already been recruited in this trial.
  14. Patients who do not understand the nature, the scope and the consequences of the clinical trial.
  15. Patient who might be dependent on the sponsor, the study site or the investigator.
  16. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 Nr. 4 AMG.

Exclusion criteria 2 - FRAIL arm:

  1. Patients <70 years of age.
  2. Papillary cancer, cholangiocellular carcinoma, neuro-endocrine tumors.
  3. Patient has received any other investigational product within 28 days prior study entry.
  4. Patient is < 5 years free of another primary malignancy (except: not currently clinically significant nor requiring active intervention)
  5. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  6. Any chemotherapy at study start.
  7. Any psychiatric illness that would affect the patient's ability to understand the demands of the clinical trial.
  8. 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.
  9. Patient has already been recruited in this trial.
  10. Patients who do not understand the nature, the scope and the consequences of the clinical trial.
  11. Patient who might be dependent on the sponsor, the study site or the investigator.
  12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 Nr. 4 AMG.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02812992
Other Study ID Numbers  ICMJE AIO-GER-0115
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AIO-Studien-gGmbH
Study Sponsor  ICMJE AIO-Studien-gGmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias Ebert, Prof. Universitätsklinikum II. Medizinische Klinik
PRS Account AIO-Studien-gGmbH
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP