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

Adenocarcinoma Pancreas Clinical Trial

— GrantPax  

Official title:

A Multicenter Phase 4 Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812992
• Other study ID #: AIO-GER-0115
• Status: Completed
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: February 2021

Study information

• Verified date: August 2021
• Source: AIO-Studien-gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2021
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma Pancreas

Intervention

Drug:
• Nab-paclitaxel

• Gemcitabine

Other:
• Best Supportive Care

Locations

Country	Name	City	State
Germany	Universitätsklinikum Mannheim II. Medizinische Klinik	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
AIO-Studien-gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CGA [Comprehensive Geriatric Assessment]	Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC	4 weeks
Secondary	ECOG [Eastern Cooperative Oncology Group]	Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC	4 weeks
Secondary	ADL (Barthel) [Activities of Daily Living]	Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC	4 weeks
Secondary	IADL (Lawton/Browdy) [Instrumental Activities of Daily Living]	Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC	4 weeks
Secondary	G8-Questionnaire	Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC	4 weeks
Secondary	CR [Complete Response]		12 months
Secondary	PR [Partial Response]		12 months
Secondary	DCR [Disease Control Rate]		12 months
Secondary	ORR [Objective Response Rate]		12 months
Secondary	AEs/SAEs [Adverse Events/Serious Adverse Events]		12 months
Secondary	PFS [Progression Free Survival]		12 months
Secondary	OS [Overall Survival]		12 months
Secondary	Percentage of patients receiving at least one chemotherapy in each treatment group		12 months
Secondary	Percentage of patients escalating treatment		12 months
Secondary	Duration of treatment		12 months
Secondary	Cumulative dose		12 months
Secondary	QoL [Quality of Life]	time to QoL deterioration [loss of 10 points or more in QLQ-C30]	12 months
Secondary	Discrepancy between CGA strata estimation by the investigator and true CGA assessment		12 months