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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

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).

Condition or disease Intervention/treatment Phase
Adenocarcinoma Pancreas Drug: Nab-paclitaxel Drug: Gemcitabine Other: Best Supportive Care Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase 4 Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients
Actual Study Start Date : June 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
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.
Drug: Nab-paclitaxel
Other Name: Abraxane®

Drug: Gemcitabine
Active Comparator: SLOW-GO arm
Gemcitabine 1000 mg/m^2 i.v. on days D1, D8, D15 of a 28-day cycle.
Drug: Gemcitabine
Active Comparator: FRAIL arm
Best supportive care as determined by the investigator.
Other: Best Supportive Care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. CR [Complete Response] [ Time Frame: 12 months ]
  7. PR [Partial Response] [ Time Frame: 12 months ]
  8. DCR [Disease Control Rate] [ Time Frame: 12 months ]
  9. ORR [Objective Response Rate] [ Time Frame: 12 months ]
  10. AEs/SAEs [Adverse Events/Serious Adverse Events] [ Time Frame: 12 months ]
  11. PFS [Progression Free Survival] [ Time Frame: 12 months ]
  12. OS [Overall Survival] [ Time Frame: 12 months ]
  13. Percentage of patients receiving at least one chemotherapy in each treatment group [ Time Frame: 12 months ]
  14. Percentage of patients escalating treatment [ Time Frame: 12 months ]
  15. Duration of treatment [ Time Frame: 12 months ]
  16. Cumulative dose [ Time Frame: 12 months ]
  17. QoL [Quality of Life] [ Time Frame: 12 months ]
    time to QoL deterioration [loss of 10 points or more in QLQ-C30]

  18. Discrepancy between CGA strata estimation by the investigator and true CGA assessment [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02812992


Locations
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Germany
Universitätsklinikum Mannheim II. Medizinische Klinik
Mannheim, Germany, 68167
Sponsors and Collaborators
AIO-Studien-gGmbH
Investigators
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Principal Investigator: Matthias Ebert, Prof. Universitätsklinikum II. Medizinische Klinik

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT02812992    
Other Study ID Numbers: AIO-GER-0115
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs