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Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

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Anti-Infective Agents

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Gemcitabine

Paclitaxel

Hydroxychloroquine

Albumin-Bound Paclitaxel

Pancrelipase

Pancreatin

Antimetabolites

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

Gemcitabine and Abraxane will be administered on an outpatient basis on Days 3, 10, 17, 31, 38, and 45 as an intravenous infusion. The dose on Day 3 will be 1000 mg/m of gemcitabine followed by a 125 mg/m2 of abraxane and the infusion will take 1 hour. The second dose and infusion time may be decreased. Prior to each gemcitabine infusion, subjects will be pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.

Gemcitabine and Abraxane will be administered on an outpatient basis on Days 3, 10, 17, 31, 38, and 45 as an intravenous infusion. The dose on Day 3 will be 1000 mg/m of gemcitabine followed by a 125 mg/m2 of abraxane and the infusion will take 1 hour. The second dose and infusion time may be decreased. Prior to each gemcitabine infusion, subjects will be pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.

Hydroxychloroquine is an oral drug (capsule) that subjects will take once or twice a day at home. The dose of hydroxychlorquien will be 1200mg. This is an experimental drug. Subjects will take their first dose of hydroxychloroquine on Day 1 (48 hours before the first infusion of gemcitabine/abraxane), and will continue to take it every day until the day before surgery.

gemcitabine

abraxane

hydroxychloroquine

Herbert Zeh, MD

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.

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

The number of patients who exhibited an Evans grade Histologic response (I, IIA, IIB, or III) to pre-operative gemcitabine / nab-paclitaxel. Histological response validated scoring system by Evans is as follows: Grade I: 1-9% tumor destruction, Grade II: 10 - 90%, Grade III: \>90% tumor destruction (Grade IIA = 10-50% of tumor cells destroyed; Grade IIB = 50-90% of tumor cells destroyed), Grade IV: Absence of viable tumor cells.

The mean age of patients at the time of diagnosis of disease (as a variable in the proportional odds logistic regression, secondary analysis of Evans Grade).

Tumor size as measured via computerized tomography (CT) scan (as a variable in the proportional odds logistic regression, secondary analysis of Evans Grade).

The number of participants in cancer diagnosis stage groups. Stage 0: cancer hasn't spread to nearby tissues/located in the same of origin.Stage I: cancers hasn't grown deeply into nearby tissues or spread to lymph nodes or other parts of the body. Stage II and III: cancers have grown more deeply into nearby tissues (may have metastasized to lymph nodes but not other parts of the body). Stage IV: most advanced stage (metastatic cancer) ; cancer has spread to other parts of the body. Stages subdivided further into the categories "A" (less agressive disease) and "B" (more advanced cancer). Example: stage IIA is less aggressive than stage IIB, but stage IIIA is more aggressive than stage IIB. (Stage variable used in the proportional odds logistic regression, secondary analysis of Evans Grade).

The number of participants in having each type of surgical resection procedure: Celiac Axis Resection With Distal Pancreatectomy (DPCAR) (Modified Appleby), Distal Pancreatectomy, Total Pancreatectomy, or Whipple. (Operation variable used in the proportional odds logistic regression, secondary analysis of Evans Grade).

The number of participants who had robotic resection surgery. (Robotic surgery variable used in the proportional odds logistic regression, secondary analysis of Evans Grade).

The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero.

Levels of Carbohydrate antigen 19-9 (CA19-9) response to pre-operative gemcitabine/ nab-paclitaxel measured in the serum (original scale)

Levels of Carbohydrate antigen 19-9 (CA19-9) response to pre-operative gemcitabine/ nab-paclitaxel measured in the serum (original scale).

The proportion of participants with positive (disease) lymph nodes involvement.

The proportion of participants having resection for cure or complete remission, in which the surgical margins are negative for tumor cells. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

Nathan Bahary, MD

Associate Professor of Medicine

Gemcitabine and Abraxane administered as an intravenous infusion on Study Days 3, 10, 17, 31, 38, and 45. Day 3 dosing: 1 hour infusion - 1000 mg/m\^2 of gemcitabine followed by a 125 mg/m\^2 of abraxane. Prior to each gemcitabine infusion, subjects were pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.

Gemcitabine + Abraxane

Gemcitabine and Abraxane administered as an intravenous infusion on Study Days 3, 10, 17, 31, 38, and 45. Day 3 dosing: 1 hour infusion - 1000 mg/m\^2 of gemcitabine followed by a 125 mg/m\^2 of abraxane. Prior to each gemcitabine infusion, subjects were pre-medicated with an FDA-approved anti-emetic (anti-nausea medication) in an effort to prevent nausea, at the discretion of the study physician.

Hydroxychloroquine oral capsules taken once or twice a daily at a dose of 1200mg. The first dose of hydroxychloroquine taken on Day 1 (48 hours before the first infusion of gemcitabine/abraxane), and continued daily until one day before surgery.

Gemcitabine + Abraxane and Hydroxychloroquine

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Barbara Stadterman

Evans grade - I

Evans grade - IIA

Evans grade - IIB

Evans grade - III

Patients who went to surgery and were evaluable for Evans Grade Histopathologic Response.

Evans Grade Histopathologic Response

Age at Diagnosis

CT Tumor Size

Not Available

Cancer Diagnosis Stage

DPCAR

Distal Pancreatectomy

Total Pancreatectomy

Whipple

Type of Surgical Procedure (Operation)

Yes - robotic surgical resection procedure

No - not robotic surgical resection procedure

Robotic Resection Surgery

Age-Adjusted CCI=2

Age-Adjusted CCI=3

Age-Adjusted CCI=4

Age-Adjusted CCI=5

Age-Adjusted CCI=6

Age-Adjusted CCI=7

Age-Adjusted CCI=8

Age-Adjusted Charlson Comorbidity Index

Participants that were assigned to treatment and did not withdraw consent prior to being given drug.

Carbohydrate Antigen 19-9 (CA19-9) Response

Positive Lymph Node Involvement

Rate of R0 Resection

Overall Study

Spots Global Cancer Trial Database for Randomized Phase II Trial of Pre-Operative Gemcitabine and Nab Paclitacel With or With Out Hydroxychloroquine

Trial Identification

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Study Description

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