July 2016 VOL 7, NO 6

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Clinical Trials Tracker

Select Ongoing Trials Currently Enrolling Patients with Colorectal Cancer

The following are a selection of key clinical trials that are currently recruiting patients for inclusion in investigations of new therapies or new combinations of available therapies for patients with colorectal cancer. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

1. Xilonix in Patients with Advanced Colorectal Cancer

This randomized, parallel-assignment, double-blind, phase 3 clinical trial evaluates whether Xilonix, a monoclonal antibody, can prolong life in patients with co­lorectal carcinoma that is refractory to standard therapy. Men and women aged ≥18 years with pathologically confirmed metastatic or unresectable colorectal carcinoma and with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive Xilonix or placebo.

The primary outcome measure is overall survival. The secondary outcome measures include change in lean body mass, quality of life, progression-free survival, and objective response rate. This study plans to enroll 600 patients at multiple locations across the United States. For more information, contact Michael Stecher, MD, at 512-386-2900. The NLM Identifier is NCT01767857.

2. Fruquintinib versus Best Supportive Care in Patients with Advanced Colorectal Cancer After Previous Chemotherapy

This phase 3, randomized, parallel-assignment, double-blind clinical trial evaluates the efficacy and safety of fruquintinib in the treatment of patients with metastatic colorectal cancer that has progressed after second-line or higher standard chemotherapy. Men and women aged 18 to 75 years with an ECOG performance status of 0 or 1, and with at least 1 measurable lesion, may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive fruquintinib or placebo.

The primary outcome measure is overall survival. The secondary outcome measures include progression-free survival, objective response rate, disease control rate, and safety and tolerance. This study expects to enroll 400 patients at multiple locations in China. For more information, contact Ye Hua, MD, at yeh@hmplglobal.com; or Songhua Fan, MD, at songhuaf@hmplglobal.com. The NLM Identifier is NCT02314819.

3. Intraoperative Chemotherapy with 5-FU for Patients with Colorectal Cancer Receiving Curative Resection

This phase 3, single-blind, parallel-assignment, randomized study is assessing the efficacy and safety of intraoperative chemotherapy with fluorouracil (5-FU) for patients with colorectal cancer receiving curative resection. Men and women aged 18 to 75 years with histologically confirmed adenocarcinoma of the colon and rectum and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will undergo surgery alone or surgery plus chemotherapy with 5-FU.

The primary outcome measure is disease-free survival. The secondary outcome measures include disease-free survival and safety profiles. This study plans to enroll 1246 patients in China. For more information, contact Xiaojun Wu, MD, PhD, at wuxj@sysucc.org.cn. The NLM Identifier is NCT01465451.

4. Masitinib plus FOLFIRI versus Placebo plus FOLFIRI in the Second-Line Treatment of Patients with Metastatic Colorectal Cancer

The purpose of this phase 3, single-group, open-label clinical trial is to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, fluorouracil, and folinic acid) versus placebo plus FOLFIRI in the second-line treatment of patients with colo­rectal cancer. Men and women aged ≥18 years with nonresectable metastatic colorectal cancer with a life expectancy of >3 months and an ECOG performance status ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive masitinib plus FOLFIRI or placebo plus FOLFIRI.

The primary outcome measure is overall survival. The secondary outcome measures include survival rate, progression-free survival, time to disease progression, best response, quality of life, pharmacogenomics assessment, and safety profile. This study expects to enroll 550 patients in Canada. For more information, contact Olena Vlasyuk, MD, at olena.vlasyuk@ab.science.com. The NLM Identifier is NCT02605044.

5. Perioperative FOLFIRI versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer After Oxaliplatin Therapy

This phase 3, open-label, parallel-assignment, randomized clinical trial is comparing perioperative FOL­FIRI and adjuvant FOLFIRI in patients with resectable advanced colorectal cancer who were previously exposed to oxaliplatin. Men and women aged 18 to 80 years with histologically confirmed colorectal adenocarcinoma and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive perioperative FOLFIRI or adjuvant FOLFIRI.

The primary outcome measure is progression-free survival. The secondary outcome measures include overall survival, R0 resection rate, toxicity, and quality of life. This study expects to enroll 360 patients in China. For more information, contact Jian Xiao, MD, at xiao_jian@139.com. The NLM Identifier is NCT02087475.

6. Pembrolizumab versus Chemotherapy in Microsatellite Instability-High or Mismatch Repair Deficient Stage IV Colorectal Cancer

The purpose of this phase 3, randomized, open-label, parallel-assignment clinical trial is to determine whether pembrolizumab will prolong progression-free survival compared with standard chemotherapy in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) stage IV colorectal cancer. Men and women aged ≥18 years with a locally confirmed dMMR or MSI-H stage IV colorectal carcinoma and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive pembrolizumab or standard chemotherapy.

The primary outcome measure is progression-free survival. The secondary outcome measures include overall response rate and overall survival. This study expects to enroll 270 patients at multiple locations in the United States and abroad. For more information, call 888-577-8839. The NLM Identifier is NCT02563002.

7. Capecitabine plus Bevacizumab versus Capecitabine plus Bevacizumab and Irinotecan as First-Line Therapy in Patients with Metastatic Colorectal Cancer

This randomized, single-group assignment, open-label, phase 3 clinical trial is assessing the efficacy of capecitabine plus bevacizumab versus capecitabine plus bevacizumab plus irinotecan in patients with metastatic colorectal cancer. Men and women aged ≥18 years with stage IV colorectal cancer and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive capecitabine plus bevacizumab followed by capecitabine plus irinotecan and bevacizumab in case of disease progression, or capecitabine plus irinotecan and bevacizumab.

The primary outcome measure is time of failure strategy. The secondary outcome measures include objective response rate, overall survival, quality of life, and progression-free survival. This study plans to enroll 516 patients in Germany. For more information, contact Volker Heinemann, MD, at volker.heinemann@med.uni-muenchen.de. The NLM Identifier is NCT01249638.

8. FOLFIRI plus Cetuximab Until Disease Progression versus FOLFIRI plus Cetuximab for 8 Cycles Followed by Cetuximab Alone Until Disease Progression in First-Line Treatment of Patients with RAS and BRAF Wild-Type Metastatic Colorectal Cancer

This randomized, open-label, parallel-assignment, phase 3 clinical trial is investigating whether cetuximab alone (given until progression or cumulative toxicity) after 8 cycles of FOLFIRI plus cetuximab results in a noninferior progression-free survival when compared with continuous FOLFIRI plus cetuximab (given until progression or cumulative toxicity). Men and women aged ≥18 years with a histologically proven diagnosis of colorectal adenocarcinoma with RAS and BRAF wild-type disease and with an ECOG performance status of 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive FOLFIRI plus cetuximab until disease progression or FOLFIRI plus cetuximab for 8 cycles followed by cetuximab alone until disease progression.

The primary outcome measures are progression-free survival and the incidence of grade 3/4 adverse events. The secondary outcome measures include response rate, early tumor shrinkage assessed by response rate at week 8, overall survival, cetuximab-related skin toxicity, safety profile, and quality of life. This study plans to enroll 600 patients in Italy. For more information, contact Armando Orlandi, MD, PhD, at armando.orlandi@edu.rm.unicatt.it. The NLM Identifier is NCT02484833.

9. Oxaliplatin, Leucovorin Calcium, and Fluorouracil with or without Celecoxib in Patients with Stage III Colon Cancer Previously Treated with Surgery

This phase 3, randomized, double-blind, parallel-assignment clinical trial is evaluating the efficacy of oxaliplatin plus leucovorin calcium and fluorouracil with or without celecoxib in patients with stage III colon cancer that was previously treated with surgery. Men and women aged ≥18 years with a histologically documented adenocarcinoma of the colon and an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive FOLFOX plus placebo (12 treatments), FOLFOX plus celecoxib (12 treatments), FOLFOX plus placebo (6 treatments), or FOLFOX plus celecoxib (6 treatments).

The primary outcome measure is disease-free survival, and the secondary outcome measure is overall survival. This study plans to enroll 2500 patients at multiple locations in the United States and abroad. For more information, contact Jeffrey A. Meyerhardt, MD, MPH, at 617-632-5136. The NLM Identifier is NCT01150045.

10. Regorafenib as Single Agent in Patients with Metastatic Colorectal Cancer with Any RAS or BRAF Mutation Previously Treated with FOLFOXIRI plus Bevacizumab

This open-label, single-group assignment, phase 2 clinical trial is evaluating the efficacy of single-agent regorafenib in the second-line treatment of patients with metastatic colorectal cancer with any RAS or BRAF mutation who were previously treated with FOLFOXIRI plus bevacizumab in terms of progression-free survival at 6 months. Men and women aged ≥18 years with stage IV metastatic colorectal cancer with any RAS or BRAF mutation and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive regorafenib.

The primary outcome measure is progression-free survival at 6 months. The secondary outcome measures include objective response rate, disease control rate, time to progression, and overall survival. This study expects to enroll 53 patients in Spain. For more information, contact Inmaculada Ruiz de Mena, PhD, at ttd@ttdgroup.org. The NLM Identifier is NCT02175654.

11. Colectomy in Patients with Asymptomatic and Unresectable Stage IV Colon Cancer

This randomized, parallel-assignment, open-label, phase 3 clinical trial is assessing whether overall survival and quality of life are improved in patients with asymptomatic colon cancer and unresectable liver metastasis that has been treated with resection of the primary tumor followed by chemotherapy versus chemotherapy alone. Men and women aged 18 to 75 years with pathologically confirmed colon adenocarcinoma and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive colectomy followed by chemotherapy versus chemotherapy alone.

The primary outcome measure is overall survival. The secondary outcome measures include quality of life, postoperative complications, progression-free survival, time to metastatic progression, and the rate of secondary curative resection. This study expects to enroll 278 patients in France. For more information, contact Mehdi Karoui, MD, PhD, at 331-42-17-56-51. The NLM Identifier is NCT02363049.

12. Regorafenib or Standard of Care After Adjuvant FOLFOX in Patients with Stage IIIC Colorectal Cancer

The purpose of this randomized, open-label, parallel-assignment, phase 2 clinical trial is to determine whether the addition of regorafenib after the completion of FOLFOX improves treatment compared with standard of care (no further treatment). Men and women aged ≥18 years with stage IIIC colorectal cancer and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive regorafenib or standard of care.

The primary outcome measure is finding the starting dose of regorafenib and the number of patients completing all 6 cycles. The secondary outcome measures include overall survival, number of adverse events, and disease-free survival. This study plans to enroll 264 patients in Florida. For more information, contact Melissa Pope at 281-863-6544, or melissa.pope@mckesson.com. The NLM Identifier is NCT02425683.

13. Pembrolizumab plus Azacitidine in Patients with Chemorefractory Metastatic Colorectal Cancer

This open-label, single-group assignment, phase 2 clinical trial is evaluating the antitumor activity, safety, and tolerability of pembrolizumab in combination with azacitidine in patients with chemorefractory metastatic colorectal cancer without any further standard treatment options. Men and women aged ≥18 years with metastatic colorectal cancer that has been previously treated with currently approved standard therapies and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive pembrolizumab and azacitidine.

The primary outcome measure is objective response rate. This study expects to enroll 40 patients in Pennsylvania. For more information, contact Natalie Streeter at 412-235-1276, or streeternr@upmc.edu. The NLM Identifier is NCT02260440.

14. Gemcitabine plus Docetaxel in Patients with Relapsed or Refractory Metastatic Colorectal Adenocarcinoma

This single-group assignment, open-label, phase 2 clinical trial is assessing the efficacy of gemcitabine plus docetaxel chemotherapy in patients with relapsed or refractory metastatic colorectal cancer with methylated CHFR and/or microsatellite instability phenotype. Men and women aged ≥18 years with a histologically or cytologically confirmed metastatic or unresectable adenocarcinoma of the colon or rectum and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive gemcitabine plus docetaxel.

The primary outcome measure is response rate. The secondary outcome measures include progression-free survival, overall survival, CHFR methylation, global methylation, and quality of life. This study expects to enroll 40 patients in the United States and the Netherlands. For more information, contact Rosalind Walker, RN, at 410-955-9628, or rwalker3@jhmi.edu. The NLM Identifier is NCT01639131.

15. FOLFOX plus Bevacizumab versus FOLFOXIRI plus Bevacizumab as First-Line Treatment of Patients with Previously Untreated Metastatic Colorectal Cancer and ≥3 Circulating Tumoral Cells

This phase 3, randomized, open-label, parallel-assignment clinical trial is evaluating FOLFOX (folinic acid, fluorouracil, and oxaliplatin) plus bevacizumab versus FOLFOXIRI (folinic acid, fluorouracil, oxaliplatin, and irinotecan) plus bevacizumab as first-line treatment for patients with previously untreated metastatic colorectal cancer and ≥3 circulating tumoral cells. Men and women aged 18 to 70 years with histologically confirmed adenocarcinoma of the colon or rectum, an ECOG performance status of 0 or 1, and a life expectancy of at least 3 months may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive FOLFOX6 plus bevacizumab or FOLFOXIRI plus bevacizumab.

The primary outcome measure is progression-free survival. Secondary outcome measures include overall survival, response rate, and adverse events. This study plans to enroll 350 patients in Spain. For more information, contact Inmaculada Ruiz de Mena, PhD, at ttd@ttdroup.org. The NLM Identifier is NCT01640405.

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