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ProtocolTrial Name and Objective
070806

Autophagy and Anti-Angiogenesis in Metastatic Colorectal Carcinoma: A Phase II trial of Hydroxychloroquine to Augment Effectiveness of Chemotherapy and Bevacizumab (AAA-CRC). A Study of the Cancer Institute of New Jersey Oncology Group (CINJOG)

The usual treatment for colon cancer that has recurred (returned) after surgical removal or that has spread beyond where surgery can cure it is chemotherapy. The current standard treatments include chemotherapy plus an antiangiogenesis drug (prevents the growth of cancer blood vessels). The chemotherapy consists of oxaliplatin given intravenously (by vein) and either or capecitabine (oral 5FU) given as pills. The antiangiogenesis drug is bevacizumab given by vein. This therapy shrinks cancer (remission) in about half the patients treated. However, some patients do not get shrinkage or the shrinkage is only temporary. Hydroxychloroquine is an older drug used to treat malaria, which may have new use in cancer to prevent cancer cells from becoming resistant to chemotherapy. The purpose of this study is to try to determine if adding hydroxychloroquine to a standard treatment for colon cancer will allow more patients to have tumor shrinkage or tumor shrinkage for a longer time
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071405

BrUOG 276: A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer

1) To evaluate the safety of the addition of ADXS11-001 to standard chemoradiation for patients with anal cancer.
2) To evaluate the 6-month clinical complete response rate for patients with anal cancer treated with ADXS11-001 mitomycin, 5-FU and IMRT.
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071407

PROGNOSTIC FACTORS FOR INCIDENTAL GALLBLADDER CANCER

The goal of this study is to evaluate whether age, sex, presence of inflammation, grade, stage, or inadvertent gallbladder perforation affect survival of patients with incidental gallbladder cancer
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071411

Retrospective Comparative Analysis of Hematologic Toxicities in Patients Receiving Chemo-Radiotherapy in Rectal Cancers Versus Chemotherapy in Colon Cancers.

To quantify bone marrow toxicity after radiation therapy in rectal cancer patients compared to bone marrow toxicity without radiation therapy in colon cancer patients.
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001007

Analysis of HMGI-C and HMGI-Y expression human benign and malignant tissues

examine the expression profiles of HMGI-C and HMGI-Y proteins in malignant and benign colon tumors.
compare the expression profile of HMGI-C and I-Y in colon tumors with other tumors, for example, breast adenocarcinomas and thyroid carcinomas.
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131307

Couple-Focused Intervention for Colorectal Cancer Screening

Specific Aim 1:To compare the efficacy of three interventions: Enhanced Couple-Tailored Intervention (E-CTI), an Enhanced Couples' Generic Intervention (E-GCI), and a Generic Print Intervention (GP) on couples' CRCS.
Hypothesis:CRCS rates at follow-up will be 22-30% in E-CTI, 12-15% in E-GCI, and 8% in GP.

Specific Aim 2:To evaluate the individual (perceived risk, decisional balance, planning, intentions) and relationship-level (relationship perspective, support for spouse screening, couples'discussions) factors which mediate E-CTI effects on couples' CRCS when compared with E-GCI and GP.
Hypothesis: E-CTI will result in significantly higher risk, more positive decisional balance, greater planning, higher CRCS intentions, adoption of greater relationship perspective on CRCS, more support for the partner's CRCS, and more frequent CRCS discussions when compared with E-GCI and GP, and that the meditational effect will be stronger in E-CTI.

Exploratory Aim: To evaluate the individual (gender, baseline intentions, support for spouse's screening, insurance status) and relationship-level (marital quality) factors which moderate E-CTI effects on couples' CRCS practices when compared with E-GCI and GP.
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071409

Retrospective and Prospective review of Patients with Metastatic colorectal cancer with ≥ 24 month survival

Review the characteristics and the treatment of all patients with metastatic colon cancer who have survived more than two years after diagnosis of metastatic disease.
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131501

Improving Patient Access to Quality Cancer Treatment (IMPACT)

Specific Aims for Phase I
Develop a survey instrument to collect data on pre- Patient Protection and Affordable Care Act (PPACA) implementation and early phase implementation that may affect access to cancer care, treatment patterns, and outcomes in New Jersey.
a) Examine disparities in access to care and patient experiences among cancer cases by insurance type, comorbidities and various demographic subgroups.
b) Examine the prevalence of concurrent medication use among cancer cases who are undergoing or have undergone cancer-related drug therapies (e.g. chemotherapy, hormone therapy)

Specific Aims for Phase II

1. Use pilot data derived from this project to demonstrate the feasibility and value of collecting population-based patient survey data on New Jersey cancer cases.
2. Expand the survey data collection to New Jersey cancer cases diagnosed and treated in later years to further examine the impact of PPACA implementation (e.g. Medicaid expansion) on access to care.
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001307

Molecular Analysis of Rare Tumors Subclasses

The overall aim is to determine what set of genomic alterations are present in ampullary cancers. If we find that, similar to our index case, activating mutations in tyrosine kinases are present in a significant subset of these cancers, this finding may lead to novel therapeutic strategies for these cancers.
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001406

Clinical Evaluation of Molecular Changes Underlying Malignant Progression in Barrett's Esophagus

To develop and validate quantitative RT-PCR, immunohistochemistry and Fluorescent in-situ hybridization (FISH) based diagnostic assays against cytogenetic events that may predict higher risk of development EA in patients with BE.
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071008

CALGB C80702: A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer

To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy (FOLFOX) or standard chemotherapy with 3 years of celecoxib 400 mg daily.
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051304

Phase IB Study of MK-3475 in Subjects with Select Advanced Solid Tumors

To evaluate preliminary signals of potential anti-tumor activity of MK-3475
in subjects with a given a histopathologic type of PD-L1 positive advanced solid tumor based on RECIST 1.1 as determined by the investigator in specific tumor indications
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071306

DEK-DKK1-P102: A Two Part, Phase 1, Multi-center, Open-label Study of DKN-01 in Combination with Weekly Paclitaxel; Arm A: A Dose-Escalation Study in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors; Arm B: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors

Primary Objective
The primary objective of this study is to characterize the safety and tolerability of DKN-01 in combination with weekly paclitaxel in patients with refractory/recurrent esophageal or gastro-esophageal junction cancer.

Secondary Objectives
The secondary objectives of this study are:
h To estimate the overall response rate (ORR) of patients with refractory/recurrent esophageal or gastro-esophageal junction cancer treated with DKN-01 in combination with paclitaxel.
h To estimate progression free survival (PFS), duration of response (DoR), and overall survival (OS) of patients with refractory/recurrent esophageal or gastro-esophageal junction cancer treated with DKN-01 in combination with paclitaxel.
h To characterize the pharmacokinetics of DKN-01 in combination with paclitaxel in patients with refractory/recurrent esophageal or gastro-esophageal junction cancer
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071401

CALGB A021202: Prospective Randomized Phase II Trial of Pazopanib (NSC # 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors

Primary Objective
For patients with progressive carcinoid tumors, progression-free survival (PFS defined by central review according to RECIST 1.1) will be compared between patients randomized to treatment with pazopanib versus placebo.

Secondary Objectives
Overall Survival will be compared between treatment arms.
Objective Response Rate duration of response, and time to treatment failure will be compared between treatment arms.
Progression Free Survival as assessed by central radiology review and local radiology review will be compared overall and within treatment arms.
PFS at 6 months and 12 months will be estimated within each treatment arm.
Safety and Tolerability of treatment with pazopanib/placebo will be evaluated within each treatment arm.
Biochemical response (for chromogranin A, defined as a decrease of 50% or more in plasma chromogranin A levels from baseline and for 5-HIAA, defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of CGA and 5-HIAA.
PFS and other indicators of efficacy will be estimated in patients who crossover to pazopanib from placebo.
Imaging objectives
Average time to submission of scans to the ICL and average ICL 'turn-around' time will be estimated.
Discordance between the local and central radiology review in assessment of progression will be estimated.
The rates and quality of radiographic progression (pre-study, on-study, and post-progression) will be characterized.
Quality of life objectives
To assess for differences in QOL-related domains between the two treatment groups (pazopanib versus placebo)
To determine if the more brief measures of QOL-related domains provide comparable information to that which is provided by the longer assessments (EORTC, NET21)
To provide validation data for the EORTC NET21 module in terms of responsiveness over time and differences across arms
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071403

Neogenix0901: A Phase 1/2 Therapeutic, Open Label, Multi-Center Clinical Trial of NPC-1C, a Chimeric Monoclonal Antibody in Adults with Recurrent, Locally Advanced Unresectable or Metastatic Pancreatic and Colorectal Cancer after Standard Therapy

Determine the safety and tolerability of escalating doses of NPC-1C (NEO-102) monoclonal antibody therapy in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer or metastatic colorectal cancer that express NPC-1C target on tumor;
h Using the recommended phase 2 dose (RP2D) evaluate the overall survival (OS) associated with administration of NPC-1C(NEO-102) in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer or metastatic colorectal cancer, that express NPC-1C target on tumor
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051406

NCI/CTEP #9571: A Phase IB Study of the Combination of AZD6244 Hydrogen Sulfate (Selumetinic) and Cyclosporin A (CsA) in Patients with Advanced Solid Tumors with an Expansion Cohort in Metastatic Colorectal Cancer

Primary Objective: To determine the maximum tolerated dose (MTD)and dose-limiting toxicities (DLT) of the combination of AZD6244 and cyclosporin A in adult patients with advanced solid tumors.
Seconday Objectives: (1) To determine the safety profile and tolerability of thsi regimen in this patient population. (2) To determine the pharmacokinetics of the combination. (3) To evaluate the selected biomarkers of drug effect in patients with advanced solid tumors or metastatic CRC. (4) Evaluate the activity of the combination in terms of objective response rate (per RECIST 1.1), overall survival, and progression-free survival.
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071410

TO-TAS-102-401: AN OPEN-LABEL EXPANDED ACCESS STUDY OF TAS-102 IN PATIENTS WITH METASTATIC COLORECTAL CANCER REFRACTORY TO OR FAILING STANDARD CHEMOTHERAPY

TO provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated, in the time period between completion of the Phase 3 clinical trial protocol TPU-TAS-102-301 and prior to TAS-102 being commercially available. This is an unmet clinical need
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