Clinical trialPhase 2Completed
Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel
Randomized Crossover Trial to Assess the Effects and Quality of Life in Patients With Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine in Combination With Nab-paclitaxel: QOLINPAC
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- April 2014
- Expected end
- 29 April 2019
- Enrollment
- 146 participants
- Sites
- 18
- Primary outcomes
- Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos); QOL Global Health Status Deterioration-free Median Survival
- Sponsor
- Other
- Results posted
- 2019-10-24
- Last update
- 6 November 2019
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Brief summary public domain (ClinicalTrials.gov)
This was a quality of life (QOL) study done in the context of a randomized trial in locally advanced or metastatic pancreatic cancer. Eligible patients were randomized to receive either the combination of nab-paclitaxel/gemcitabine or standard gemcitabine monotherapy. The combination regimen of nab-paclitaxel and gemcitabine showed improved efficacy with acceptable toxicity in this disease setting in first-line and was approved for this indication. The study design allowed patients in standard treatment to receive the combination treatment after first tumour progression. The proposed study explored the impact of treatment on the QOL scores and compared the times to definitive deterioration of the QOL scores using the validated EORTC QLQ-C30 questionnaire. Efficacy and safety were secondary endpoints and were reported descriptively. Molecular studies will be performed on blood and tissue samples as avaialble and will be reported separately.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos) [From date of randomisation to 3, 6 and 12 months respectively]. Number, percentage of participants. Rate at 3 months (percentage): Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 89; Arm B (Gemcitabine) (n=73): 73. Rate at 6 months (percentage): Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 74; Arm B (Gemcitabine) (n=73): 59. Rate at 12 months (percentage): Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 40; Arm B (Gemcitabine) (n=73): 35.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
QOL Global Health Status Deterioration-free Median Survival [From date of randomisation to end of follow up (max 3 years after database lock when applicable).]. Median, Months (95% Confidence Interval). Arm A (Nab-Paclitaxel +Gemcitabine) (n=72): 10.04 (7.16 to 12.02); Arm B (Gemcitabine) (n=73): 8.02 (5.49 to 11.37).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Response [Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).]. Count Of Participants, Participants. CR or PR: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 31; Arm B (Gemcitabine) (n=73): 16. SD or PD: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 39; Arm B (Gemcitabine) (n=73): 53. Not evaluable: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 2; Arm B (Gemcitabine) (n=73): 4.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Duration of Response (in Responders) [Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).]. Median, Months (95% Confidence Interval). Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 6.3 (1.92 to 35); Arm B (Gemcitabine) (n=73): 7.4 (1.5 to 20).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Control [Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).]. Count Of Participants, Participants. CR + PR + SD: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 58; Arm B (Gemcitabine) (n=73): 60. PD: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 12; Arm B (Gemcitabine) (n=73): 9. Not evaluable: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 2; Arm B (Gemcitabine) (n=73): 4.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival [Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).]. Median, Months (95% Confidence Interval). Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 7.01 (5.45 to 8.05); Arm B (Gemcitabine) (n=73): 5.06 (3.52 to 7.00).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).]. Median, Months (95% Confidence Interval). Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 10.94 (8.97 to 15.18); Arm B (Gemcitabine) (n=73): 11.73 (8.74 to 13.44).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Laboratory Safety Assessment [Measured during treatment, from signature of informed consent to end of treatment, plus 30 days mandatory safety follow-up period. Duration of treatment was variable for each patient.]. Count Of Participants, Participants. Hemoglobin decreased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 10; Arm B (Gemcitabine) (n=74): 8. Neutrophils decreased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 31; Arm B (Gemcitabine) (n=74): 31. White blood cell count decreased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 22; Arm B (Gemcitabine) (n=74): 11. Platelet count decreased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 12; Arm B (Gemcitabine) (n=74): 11. Hyperglycemia: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 6; Arm B (Gemcitabine) (n=74): 10. Serum creatinine increased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 0; Arm B (Gemcitabine) (n=74): 2. Bilirubin increased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 3; Arm B (Gemcitabine) (n=74): 8. ALT increased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 13; Arm B (Gemcitabine) (n=74): 8. AST increased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 7; Arm B (Gemcitabine) (n=74): 8. ALP increased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 9; Arm B (Gemcitabine) (n=74): 11. Albumin decreased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 4; Arm B (Gemcitabine) (n=74): 4. Magnesium decreased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 4; Arm B (Gemcitabine) (n=74): 9. Sodium decreased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 8; Arm B (Gemcitabine) (n=74): 13. Potassium decreased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 8; Arm B (Gemcitabine) (n=74): 6. Potassium increased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 1; Arm B (Gemcitabine) (n=74): 0. Calcium decreased: Arm A (Nab-Paclitaxel + Gemcitabine) (n=72): 3; Arm B (Gemcitabine) (n=74): 2.