hydroxychloroquine and Adenocarcinoma

hydroxychloroquine has been researched along with Adenocarcinoma in 9 studies

Hydroxychloroquine: A chemotherapeutic agent that acts against erythrocytic forms of malarial parasites. Hydroxychloroquine appears to concentrate in food vacuoles of affected protozoa. It inhibits plasmodial heme polymerase. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p970)
hydroxychloroquine : An aminoquinoline that is chloroquine in which one of the N-ethyl groups is hydroxylated at position 2. An antimalarial with properties similar to chloroquine that acts against erythrocytic forms of malarial parasites, it is mainly used as the sulfate salt for the treatment of lupus erythematosus, rheumatoid arthritis, and light-sensitive skin eruptions.

Adenocarcinoma: A malignant epithelial tumor with a glandular organization.

Research

Studies (9)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Disease-free Survival (DFS)

Median number of months of disease-free survival for participants receiving study treatment. (NCT01128296)
Timeframe: Up to 30 months

Number of Participants That Experienced a Dose Limiting Toxicity (DLT)

Number of Participants at each dose level of HCQ that experienced a Dose Limiting Toxicity (DLT). (NCT01128296)
Timeframe: Up to 31 days

Overall Survival (OS)

Median number of months of overall survival for participants receiving study treatment. (NCT01128296)
Timeframe: Up to 35 months

R0 Resection Rate

Number of participants that underwent a resection with microscopically margin-negative resection in which no gross or microscopic tumor remains in the primary tumor bed (24) / number of that completed treatment (31) (NCT01128296)
Timeframe: Up to 30 months

Disease-free Survival (DFS) by CA 19-9 Response

Median number of months of disease-free survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from >0 to 225%. Per participant decreases in Ca 19-9 ranged from >0 to 100%. (NCT01128296)
Timeframe: Up to 30 months

Disease-free Survival (DFS) by Response to HCQ Treatment

Median number of months of disease-free survival in participants who did and did not experience response to HCQ treatment. Patients who had >51 % increase in their LC3-II staining were classified as having a response to HCQ. (NCT01128296)
Timeframe: Up to 30 months

Disease-free Survival by p53 Genetic Status

(NCT01128296)
Timeframe: Up to 35 months

Overall Survival (OS) by CA 19-9 Response

Median number of months of overall survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or, no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from >0 to 225%. Per participant decreases in Ca 19-9 ranged from >0 to 100%. (NCT01128296)
Timeframe: Up to 35 months

Overall Survival (OS) by p53 Mutant Status

(NCT01128296)
Timeframe: Up to 35 months

Overall Survival (OS) by Response to HCQ Treatment

Median number of months of overall survival in participants who did and did not experience response to HCQ treatment. Patients who had >51 % increase in their LC3-II staining were classified as having a response to HCQ. (NCT01128296)
Timeframe: Up to 35 months

Age at Diagnosis

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). (NCT01978184)
Timeframe: Baseline - At the time of diagnosis, prior to treatment

Carbohydrate Antigen 19-9 (CA19-9) Response

Levels of Carbohydrate antigen 19-9 (CA19-9) response to pre-operative gemcitabine/ nab-paclitaxel measured in the serum (original scale) (NCT01978184)
Timeframe: Prior to treatment (average 73.3 +/- 9.9 days prior to surgery)

Carbohydrate Antigen 19-9 (CA19-9) Response

Levels of Carbohydrate antigen 19-9 (CA19-9) response to pre-operative gemcitabine/ nab-paclitaxel measured in the serum (original scale). (NCT01978184)
Timeframe: After treatment (50-67 days post treatment/surgery)

CT Tumor Size

Tumor size as measured via computerized tomography (CT) scan (as a variable in the proportional odds logistic regression, secondary analysis of Evans Grade). (NCT01978184)
Timeframe: Baseline - At the time of diagnosis, prior to treatment

Positive Lymph Node Involvement

The proportion of participants with positive (disease) lymph nodes involvement. (NCT01978184)
Timeframe: At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)

Rate of R0 Resection

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. (NCT01978184)
Timeframe: At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)

Age-Adjusted Charlson Comorbidity Index

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. (NCT01978184)
Timeframe: Prior to treatment

Cancer Diagnosis Stage

"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)." (NCT01978184)
Timeframe: Baseline - At the time of diagnosis, prior to treatment

Evans Grade Histopathologic Response

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. (NCT01978184)
Timeframe: Up to 4 years

Robotic Resection Surgery

The number of participants who had robotic resection surgery. (Robotic surgery variable used in the proportional odds logistic regression, secondary analysis of Evans Grade). (NCT01978184)
Timeframe: At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)

Type of Surgical Procedure (Operation)

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). (NCT01978184)
Timeframe: At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)

2-month Progression-Free Survival Rate

2-month progression-free survival rate was defined as the percentage of patients absent progression (PD) or death before 2 months. Patients were considered to have experienced PD if they demonstrated either clinical deterioration resulting in withdrawal or PD per RECIST 1.0 criteria: At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. (NCT01273805)
Timeframe: Disease was evaluated radiologically at baseline and at the first restaging at 2 months.

Grade 4-5 Treatment-Related Toxicity

All grade 4-5 adverse events with treatment attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms. (NCT01273805)
Timeframe: Adverse events were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.

Overall Survival

Overall survival estimated using Kaplan-Meier (KM) methods is defined as the time from study entry to death or date last known alive. (NCT01273805)
Timeframe: All patients were followed until death. Median survival follow-up in this study cohort was 60 days (95% CI: 40-184).

Progression-Free Survival

Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to time of objective progression on CT scan or the time of death for patients with clinical deterioration resulting in withdrawal from the trial. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients without an event were censored at date of last disease evaluation. (NCT01273805)
Timeframe: Disease was evaluated radiologically at baseline and every 2 months on treatment. Median PFS follow-up in this study cohort was 46.5 days (95% CI 33-61).

Tumor Response Rate

Tumor response rate is the percentage of patients achieving complete or partial response on treatment based on RECIST 1.0 criteria. For target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR for the evaluation of non-target lesions is the disappearance of non-target lesions and normalization of tumor marker level. Appearance of one or more new lesions is classified as progression of non-target lesions. CR or PR confirmation is required >/= 4 weeks. (NCT01273805)
Timeframe: Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.

Describe the Number and Type of Observed Dose Limiting Toxcities

HCQ doses tested included 400mg, 600mg, 800mg, and 1000mg. Dose-limiting toxicities (DLTs) were defined as CTC of grade 2 or higher retinopathy or keratitis, or CTC of grade 3 or higher hematologic, skin, CNS, neuropathic, cardiac, respiratory, gastrointestinal, or renal AEs in the first cycle considered at least possibly related to HCQ. If a DLT was observed, an additional three patients were enrolled at that dose level. The maximum tolerated dose for HCQ in each arm would be defined as one dose level below that at which two or more of 6 patients experienced a DLT, or if no DLTs were observed, the highest tested dose. (NCT01026844)
Timeframe: 2 years

Determine the Pharmacokinetic (PK) Parameters of Hydroxychloroquine (HCQ) Plus Erlotinib.

PK parameter tested was dose normalized minimum steady state concentration (Cmin SS) of HCQ in micromolar per gram. Note this outcome was only analyzed for the first 21 patients enrolled, 13 on erlotinib/HCQ and 8 on HCQ arm. (NCT01026844)
Timeframe: 2 years

Objective Tumor Response Rate

Number of Response Evaluation Criteria in Solid Tumors (RECIST) responses divided by number of patients treated. Per RECIST version 1.0 complete response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions. The objective tumor response rate is the CR + PR divided by the total number of patients (NCT01026844)
Timeframe: 2 years

Trials

3 trials available for hydroxychloroquine and Adenocarcinoma

Other Studies

6 other studies available for hydroxychloroquine and Adenocarcinoma