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Regorafenib in Reducing Recurrence in Patients With Non-metastatic Rectal Cancer Who Have Completed Curative-Intent Treatment | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Regorafenib in Reducing Recurrence in Patients With Non-metastatic Rectal Cancer Who Have Completed Curative-Intent Treatment

(Bayer Study ONC-2013-036) A Phase II Single-Arm Study of Regorafenib Maintenance Therapy in Patients With T3, T4 or Node-Positive Rectal Cancer Patients Who Completed Curative-Intent Treatment

NCT02287727•Roswell Park Cancer Institute

View on ClinicalTrials.gov

Summary

This phase II trial studies how well regorafenib works in reducing the return of disease in patients with rectal cancer that has not spread to another place in the body who have completed curative-intent treatment. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Regorafenib may also help keep cancer from coming back after it has disappeared following the initial therapy.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the 3-year disease free survival in patients with T3, T4 or node-positive rectal adenocarcinoma who received regorafenib maintenance therapy following the completion of curative-intent standard treatment. SECONDARY OBJECTIVES: I. To determine the cumulative incidence of local recurrence, distant recurrence and overall survival at 3 years. II. To explore for biomarkers associated with anti-cancer effects of regorafenib maintenance therapy in curatively treated rectal cancer patients by analyzing tumor and blood samples. OUTLINE: Patients receive regorafenib orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 4 months for up to 5 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed adenocarcinoma of the rectum that was clinically staged T3, T4 or node-positive (defined as \>= N1 per American Joint Committee on Cancer \[AJCC\] 7th edition) that was treated with the following treatment with curative intent:
•* Curative surgical resection
•* Pre- or post-operative chemoradiation; and at least 3 months of adjuvant systemic chemotherapy (equivalent to 6 cycles of leucovorin calcium, fluorouracil, and oxaliplatin \[FOLFOX\] or infusional fluorouracil \[5FU\])
•No evidence of cancer within 28 days prior to start of study treatment; this should be determined by imaging of the chest, abdomen and pelvis by computed tomography (CT) and/or magnetic resonance imaging (MRI); staging of the chest using chest x-ray in lieu of CT and/or MRI should not be used for this purpose
•Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
•Consent to allowing his/her archival tumor tissues to be requested and analyzed; however, the non-availability or inadequate amount samples for analysis will not exclude the patient
•Total bilirubin =\< 1.5 x the upper limits of normal (ULN)
•Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) =\< 2.5 x ULN
•Alkaline phosphatase limit =\< 2.5 x ULN
•Lipase =\< 1.5 x the ULN
+5 more criteria

Exclusion Criteria

•Evidence of recurrence of rectal cancer prior to the start of study treatment
•Any previously untreated or concurrent cancer that is distinct in primary site or histology from rectal cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before starting study drug are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form)
•Anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 4 weeks prior to entering the study (signing of consent form) or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients on hormonal or bisphosphonate treatment for non-cancer related conditions are eligible
•Inability to start study treatment within 12 weeks following the completion of curative intent therapy for rectal adenocarcinoma
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication; minor procedures such as diagnostic laparoscopy, percutaneous biopsy and paracentesis within 14 days before start of study medication
•Patients who have not recovered from the surgical resection of rectal cancer such as wound dehiscence, non-healing wound, wound infection and fistula
•Prior use of regorafenib
•Gastrointestinal conditions that may significantly affect the absorption of regorafenib
•Uncontrolled hypertension (systolic pressure \> 140 mmHg or diastolic pressure \> 90 mmHg on repeated measurement) despite optimal medical management
•Evidence or history of bleeding diathesis or coagulopathy
+20 more criteria

Locations (3)

Roswell Park Cancer Institute

Buffalo, New York, United States

University of Rochester Medical Center - Wilmont Cancer Institute

Rocherster, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Key Dates

Start Date

March 1, 2015

Primary Completion Date

October 1, 2016

Last Updated

October 12, 2016

Conditions

Rectal AdenocarcinomaStage IIA Rectal CancerStage IIB Rectal CancerStage IIC Rectal CancerStage IIIA Rectal CancerStage IIIB Rectal Cancer

Interventions

Laboratory Biomarker Analysis

OTHER

Regorafenib

DRUG

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NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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Advanced Malignant Solid NeoplasmClinical Stage III Gastroesophageal Junction Adenocarcinoma+27 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 12, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Regorafenib in Reducing Recurrence in Patients With Non-metastatic Rectal Cancer Who Have Completed Curative-Intent Treatment

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

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