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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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071302

Examination of Intra-institutional Method of Diaphragmatic Hernia Repair Post Transhiatal Esophagectomy Compared to Traditional Repairs: A Retrospective Chart Review

Trans-hiatal esophagectomy is a procedure commonly done at CINJ/RWJ for the management of esophageal tumors. A known, but infrequent complication of this surgery are diaphragmatic herniations. We have developed a novel technique to address this and we aim to examine our experience using this technique with respect to its effectiveness and outcomes associated with it.
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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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071203

CALGB 80803: Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

Primary: 1) To induce a pCR rate of 20% in PET scan responders treated with either induction FOLFOX or carboplatin/paclitaxel, who then cross over to the other regimen during radiotherapy
Secondary: 1) To compare pCR between induction treatment arms among PET/CT responders
2) To compare pCR between induction treatment arms among PET/CT responders
3)If both treatment regimens are found to be efficacious, to directly compare pCR between induction treatment arms among non-responders
4) To determine 8-month PFS in PET/CT scan responders, and in non-responders treated with alternative crossover chemoradiotherapy
5) Estimate the PFS and overall survival, overall and among PET responders and PET/CT non-responders by induction treatment
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071304

A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients with Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases

To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy
In this study, the primary efficacy endpoint is disease-free survival (DFS) as assessed by the investigator; the secondary efficacy endpoint is overall survival. The exploratory efficacy endpoints are:
 Health-Related Quality of Life as assessed by the European Quality of Life Group five dimension 3-level and European Organization for Research and Treatment of Cancer Quality of Life-C30 questionnaires
 Biomarker evaluations
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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:
 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.
 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.
 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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