June 2014 VOL 5, NO 3

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Clinical Trials Tracker

New Clinical Trials Under Way

The following clinical trials are currently recruiting patients with colorectal cancer for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.

Adjuvant Aflibercept for Metastatic Colorectal Cancer
This phase 2, randomized, open-label efficacy study aims to evaluate whether aflibercept can reduce the chance that metastatic colorectal cancer can grow back after finishing standard treatment. The study also examines the side effects of aflibercept and the effect on quality of life, and is expected to enroll 69 patients. Patients who are aged ?18 years who have received first-line therapy for metastatic colorectal cancer are eligible to participate if other criteria are met. Those participating in the study will be randomized to receive aflibercept until progression for up to 2 years or observation with no intervention.

The primary outcome for this study is disease-free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites. Additional outcomes include adverse events for patients receiving adjuvant aflibercept up to 2 years’ duration, for patients who previously received systemic chemotherapy and surgical resection/ablation, as well as quality-of-life measurements and biomarkers in peripheral blood and fresh and archived tumor tissues. Study locations include California, Florida, New York, and Rhode Island. For more information, contact Kayla Rosati, EdM, Brown University, Providence, RI, at 401-863-3000 or Kayla_rosati@brown.edu. The NLM Identifier is NCT01669720.

RAD001, FOLFOX, and Bevacizumab in Treatment of Colorectal Carcinoma
The purpose of this phase 1/2 open-label, interventional study is to determine the safety and efficacy of using RAD001 (everolimus) in combination with FOLFOX (folinic acid, fluorouracil, oxaliplatin) and bevacizumab for the treatment of colorectal cancer. Everolimus has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation; it has been in development for patients with certain malignancies since 2002. Patients who are aged ?18 years with advanced or metastatic colorectal cancers for whom chemotherapy is indicated are eligible to participate if other criteria are met. All patients enrolled in the study will receive a combination therapy of everolimus, FOLFOX, and bevacizumab.

The primary outcomes for this study are to evaluate progression-free survival in patients receiving this combination therapy for previously untreated metastatic or advanced colorectal cancers, as well as to determine the safety of the combination at specified doses. Other outcomes include a determination of the toxicity profile and response rates of the combination, as well as serum proteomic profiles of patients treated with this therapy. The study will be conducted at Huntsman Cancer Institute and Utah Cancer Specialists, both in Salt Lake City, UT. For more information, contact Marlene Mitchell, RN, at 801-587-4779 or marlene.mitchell@hci.utah.edu, or Cindy Davidson, APRN, at 801-587-5581 or cynthia.davidson@hci.utah.edu. The NLM Identifier is NCT01047293.

Genistein in the Treatment of Metastatic Colorectal Cancer
The objective of this phase 1/2 interventional study is to assess whether combining genistein with the standard-of-care chemotherapeutic regimens reduces chemotherapy resistance and improves the response rate of patients with newly diagnosed metastatic (stage IV) colon or rectal neoplasm. It is estimated that 24 patients will be enrolled. The response rate will be measured using the radiologic Response Evaluation Criteria in Solid Tumors criteria; progression-free survival will also be assessed.

Patients who are aged ?18 years with pathologically confirmed colon or rectal carcinomas, have a plan by their treating physician to receive FOLFOX or FOLFOX-Avastin, and have an Eastern Cooperative Oncology Group performance status ?2 may be eligible to participate in the study if additional criteria are met. For more information, contact Randall F. Holcombe, MD, Icahn School of Medicine at Mount Sinai, New York, NY, at 212-659-5420 or randall.holcombe@mssm.edu. The NLM Identifier is NCT01985763.

Combination Therapy Assessment in Patients with KRAS and NRAS Wild-Type Cancer
The purpose of this phase 2 randomized trial is to assess combination therapy of PF-05212384 plus irinotecan compared with combination therapy of cetuximab plus irinotecan in patients with KRAS and NRAS wild-type metastatic colorectal cancer. Progression-free survival at 36 weeks will be evaluated as the primary outcome measure. Dose-limiting toxicities, objective response, and duration of response will also be evaluated.

Criteria for inclusion include progression following treatment for colorectal cancer with irinotecan, oxaliplatin, and fluoropyrimidine therapy in the metastatic setting; Eastern Cooperative Oncology Group performance status of 0, 1, or 2; and ?1 measurable lesion by Response Evaluation Criteria in Solid Tumors. The trial is currently recruiting an estimated 159 patients in several states, including Alabama, California, Florida, and Missouri. For additional information about the trial and eligibility, contact the PfizerCT.gov call center at 800-718-1021. The NLM Identifier is NCT01925274.

Colorectal Cancer Umbrella Protocol
The Assessment of Targeted Therapy Against Colorectal Cancer screening protocol trial is testing for biomarkers in patients with metastatic or unresectable, locally advanced colorectal cancer. The primary end point of interest is the rate of successful biomarker determination. Study participants who are eligible for inclusion will undergo a blood draw for biomarker test and will be asked whether they are able to perform normal daily activities (ie, performance status). In addition, a leftover sample of tumor tissue will be collected from a previous procedure, if available, and participants will be asked to fill out a questionnaire about their cancer symptoms. Researchers are attempting to determine whether certain biomarkers can be used to help predict which cancer drugs may work better than other drugs in different people with colorectal cancer.

This study is recruiting 660 patients and is taking place at the University of Texas MD Anderson Cancer Center in Houston. For more information about the trial and criteria for participation, contact the Principal Investigator, Scott Kopetz, MD, at 713-792-2828. The NLM Identifier is NCT01196130.

Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer
The objective of this randomized phase 1/2 study is to evaluate the safety of combination therapy with interferon, celecoxib, and rintatolimod in patients with recurrent colorectal cancer. This will also test whether the above combination can help the immune system to fight the tumors. The treatment group consists of a chemokine-­modulating regimen plus surgery, and chemokine modulatory regimen before surgical resection; the control group comprises surgical resection only, performed as standard of care for the disease.

To be eligible for inclusion, patients should be aged ?18 years, have isolated hepatic metastasis, complete resection based on preoperative imaging, and meet additional criteria. Fifty patients will be recruited for this trial. For more information, contact Principal Investigator Amer H. Zureikat, MD, at 412-623-7931 or zureikatah@upmc.edu. The NLM Identifier is NCT01545141.

Surgery Plus Sulindac or Surgery Alone
In this phase 2, prospective, randomized, double-blind trial, investigators are assessing whether sulindac improves treatment outcomes in patients undergoing surgery for advanced colorectal cancer. Patients in the treatment group will get sulindac 1 tablet twice daily, and patients in the control group receive placebo 1 tablet twice daily. Patients with histologically confirmed colorectal adenocarcinoma with metastatic disease confined to the liver, or limited extrahepatic intraabdominal disease, as well as patients with hepatic and intraabdominal metastases measurable with computed tomography, magnetic resonance imaging, and/or positron emission tomography scan are eligible for inclusion.

The study will be conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, MD, and 57 patients may be recruited. For more details about the trial and inclusion/exclusion criteria, contact the NIH Clinical Center, National Cancer Institute/Surgery Branch Recruitment Center at 866-820-4505 or ncisbirc@mail.nih.gov. The NLM Identifier is NCT01856322.

Irinotecan and BKM120 in Patients with Previously Treated Advanced Disease
The purpose of this phase 1 trial is to evaluate combination therapy of irinotecan and BKM120 in patients with advanced colorectal cancer who did not respond to or become intolerant of ?1 line of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy. The primary outcome measure is maximum tolerated dose in 28 days; approximately 30 patients will be enrolled in this study.

Patients who are aged ?18 years with histologically or cytologically confirmed metastatic or unresectable adenocarcinoma of the colon or rectum with measurable disease, Eastern Cooperative Oncology Group performance status ?2 (Karnofsky >60%), and absolute neutrophil count ?1.5 × 109/L, platelets ?100 × 109/L, hemoglobin >9 g/dL may be eligible for participation. For more information on inclusion criteria and study details, contact Principal Investigator Joaquina Baranda, MD, at 913-588-6077 or jbaranda@kumc.edu, or Stacey Purinton, RN, at 913-588-2545 or spurinton@kumc.edu. The NLM Identifier is NCT01304602.

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