Randomized Phase II Trial of Pre-Operative Gemcitabine and Nab Paclitacel With or With Out Hydroxychloroquine

Brief summary public domain (ClinicalTrials.gov)

This is a randomized phase II trial that will examine the ability of the hydroxychloroquine to improve the clinical activity of a pre-operative regimen of gemcitabine and nab-paclitaxel in subjects with potentially resectable adenocarcinoma of the pancreas. Eligible subjects will receive 2 cycles of gemcitabine and nab-paclitaxel (day 1, 8, 15) with or without hydrocychloroquine followed by surgical resection. Primary endpoint will be histologic response as graded by Evans criteria. Secondary endpoints will be CA19-9 response and PET response. Pre and post treatment tissue biopsies will be obtained to assess for levels of autophagy in tumor, liver and peripheral blood.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Evans Grade Histopathologic Response [Up to 4 years]. Number, number of participants. Evans grade - I: Gemcitabine + Abraxane (n=30): 10; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 7. Evans grade - IIA: Gemcitabine + Abraxane (n=30): 17; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 12. Evans grade - IIB: Gemcitabine + Abraxane (n=30): 3; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 13. Evans grade - III: Gemcitabine + Abraxane (n=30): 0; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 9.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Age at Diagnosis [Baseline - At the time of diagnosis, prior to treatment]. Mean, years (Standard Deviation). Gemcitabine + Abraxane (n=30): 63.6 (11.8); Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 66.1 (8.4).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

CT Tumor Size [Baseline - At the time of diagnosis, prior to treatment]. Mean, centimeters (Standard Deviation). Gemcitabine + Abraxane (n=29): 2.562069 (1.105962); Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 2.543056 (1.139370).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Cancer Diagnosis Stage [Baseline - At the time of diagnosis, prior to treatment]. Count Of Participants, Participants. IA: Gemcitabine + Abraxane (n=30): 0; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 2. IB: Gemcitabine + Abraxane (n=30): 5; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 1. IIA: Gemcitabine + Abraxane (n=30): 6; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 11. IIB: Gemcitabine + Abraxane (n=30): 19; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 20. Not Available: Gemcitabine + Abraxane (n=30): 0; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 7.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Type of Surgical Procedure (Operation) [At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)]. Count Of Participants, Participants. DPCAR: Gemcitabine + Abraxane (n=30): 2; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 0. Distal Pancreatectomy: Gemcitabine + Abraxane (n=30): 3; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 5. Total Pancreatectomy: Gemcitabine + Abraxane (n=30): 1; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 0. Whipple: Gemcitabine + Abraxane (n=30): 24; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 36.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Robotic Resection Surgery [At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)]. Count Of Participants, Participants. Yes - robotic surgical resection procedure: Gemcitabine + Abraxane (n=30): 8; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 10. No - not robotic surgical resection procedure: Gemcitabine + Abraxane (n=30): 22; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 31.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Age-Adjusted Charlson Comorbidity Index [Prior to treatment]. Count Of Participants, Participants. Age-Adjusted CCI=2: Gemcitabine + Abraxane (n=30): 3; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 1. Age-Adjusted CCI=3: Gemcitabine + Abraxane (n=30): 5; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 2. Age-Adjusted CCI=4: Gemcitabine + Abraxane (n=30): 7; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 11. Age-Adjusted CCI=5: Gemcitabine + Abraxane (n=30): 8; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 15. Age-Adjusted CCI=6: Gemcitabine + Abraxane (n=30): 5; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 8. Age-Adjusted CCI=7: Gemcitabine + Abraxane (n=30): 2; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 2. Age-Adjusted CCI=8: Gemcitabine + Abraxane (n=30): 0; Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 2.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Carbohydrate Antigen 19-9 (CA19-9) Response [Prior to treatment (average 73.3 +/- 9.9 days prior to surgery)]. Mean, units per milliliter (U/mL) (Standard Deviation). Gemcitabine + Abraxane (n=30): 351.820 (839.925); Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 1534.633 (3558.1212).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Carbohydrate Antigen 19-9 (CA19-9) Response [After treatment (50-67 days post treatment/surgery)]. Mean, units per milliliter (U/mL) (Standard Deviation). Gemcitabine + Abraxane (n=29): 319.079 (1338.259); Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 1696.710 (9850.273).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Positive Lymph Node Involvement [At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)]. Number, proportion of participants (95% Confidence Interval). Gemcitabine + Abraxane (n=30): 0.8 (0.614 to 0.923); Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 0.561 (0.397 to 0.715).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Rate of R0 Resection [At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)]. Mean, proportion of participants (95% Confidence Interval). Gemcitabine + Abraxane (n=30): 0.7 (0.506 to 0.853); Gemcitabine + Abraxane and Hydroxychloroquine (n=41): 0.829 (0.679 to 0.928).