This issue of The ASCO Post launches a Clinical Trials Resource Guide to increase awareness of NCI-funded phase I, II, and III clinical studies for your patients with advanced cancer. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
The clinical trials included here are currently recruiting patients with breast cancer, colorectal cancer, non-small cell lung cancer, and prostate cancer.
BREAST CANCER
Study Type: Randomized Phase III/Interventional
Study Title: A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
Study Sponsor and Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute
Purpose: To study early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.
Eligibility
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Primary Outcome Measures: Overall survival
Principal Investigator: Seema A. Khan, MD, Robert H. Lurie Cancer Center
For More Information: Visit ClinicalTrials.gov and refer to this study by its ClinicalTrials.gov identifier: NCT01242800
Study Type: Randomized Phase II/Interventional
Study Title: A Randomized, Open-Label Comparative Study of Combination Therapy With Cyclophosphamide and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine With or Without Trastuzumab for the Treatment of Metastatic Breast Cancer That Does Not Over-express HER-2/Neu
Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center; National Cancer Institute
Purpose: To study the side effects of giving cyclophosphamide together with vaccine therapy and to see how well it works compared with giving cyclophosphamide and vaccine therapy together with trastuzumab in treating patients with metastatic breast cancer.
Eligibility
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Primary Outcome Measures: Toxicity as assessed by NCI CTCAE v3.0; Time Frame: 3 years; Progression-free survival at 6 months; Time Frame: 3 years; HER-2/neu-specific immune responses; Time Frame: 3 years; Pharmacodynamics of peripheral CD4+CD25+ regulatory T cells; Time Frame: 3 years.
Principal Investigator: Leisha A. Emens, MD, PhD, Sidney Kimmel Comprehensive Cancer Center
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00971737
COLORECTAL CANCER
Study Type: Non-Randomized Phase 1/II/Interventional
Study Title: A Phase 1/II Study of ISIS 183750 in Combination With Irinotecan in Irinotecan-refractory Colorectal Cancer
Study Sponsor and Collaborators: National Cancer Institute
Purpose: Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the DNA of growing cancer cells and is most often used with other chemotherapy drugs. Researchers want to test irinotecan with an experimental drug, ISIS 183750, to see if the drugs are a safe and effective treatment for advanced solid tumors or colorectal cancer that has not responded to other treatments.
Eligibility
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Primary Outcome Measures: Maximum tolerate dose
Principal Investigator: Tim F. Greten, MD, National Cancer Institute
Contacts: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01675128
NON-SMALL CELL LUNG CANCER
Study Type: Non-Randomized Phase II/Interventional
Study Title: Phase II Trial of XL184 (Cabozantinib), Plus Erlotinib in Patients With Advanced EGVR-Mutant Non-Small-Cell Lung Cancer Who Have Progressed on Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
Study Sponsor and Collaborators: National Cancer Institute
Purpose: This phase II trial investigates how well cabozantinib-s-malate and erlotinib hydrochloride works in treating patients with previously treated metastatic non-small cell lung cancer. Cabozantinib-s-malate and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving cabozantinib-s-malate together with erlotinib hydrochloride may be an effective treatment for non-small cell lung cancer.
Eligibility
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Primary Outcome Measures: Objective response defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1; Time Frame: Up to 2 years
Principal Investigator: Karen Reckamp, MD, MS, Beckman Research Institute
Contacts: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01866410
Study Type: Randomized Phase II/Interventional
Study Title: A Randomized Phase II Trial of Cytotoxic Chemotherapy With or Without Epigenetic Priming in Patients With Advanced Non-Small Cell Lung Cancer
Study Sponsor and Collaborators: National Cancer Institute
Purpose: This randomized phase II trial is studying how effective azacitidine and entinostat given before chemotherapy is in treating patients with advanced non-small cell lung cancer. Drugs used in chemotherapy, such as azacitidine, irinotecan hydrochloride, gemcitabine hydrochloride, docetaxel, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine and entinostat before chemotherapy may be an effective treatment for non-small cell lung cancer.
Eligibility
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Primary Outcome Measures: Percentage of patients progression-free at 6 months from the time of randomization; Time Frame: at 6 months
Principal Investigator: Julie Brahmer, MD, Johns Hopkins University
Contacts: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01935947
PROSTATE CANCER
Study Type: Non-Randomized Phase I/Interventional
Study Title: Evaluation of Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer
Study Sponsor and Collaborators: National Cancer Institute
Purpose: Ferumoxytol is an approved iron replacement therapy agent that has some potential for use as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes that have been affected by cancer. Because ferumoxytol has not yet been approved for use as an imaging agent, researchers are interested in testing its effectiveness as a contrast agent for studies of normal lymph tissue and cancer tissue in lymph nodes of individuals with prostate cancer. The objective of this study is to evaluate the safety and effectiveness of ferumoxytol as a contrast agent in individuals who are scheduled to have prostate removal surgery to treat prostate cancer.
Eligibility
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Male
Accepts Healthy Volunteers: No
Primary Outcome Measures: To determine the optima dose of ferumoxytol for enhancing lymph nodes in patients with prostate cancer
Principal Investigator: Peter L. Choyke, MD, National Cancer Institute
Contacts: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01296139 ■
