Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer

NCT01471353 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: ONC2010-23IRB201701484
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Combining Sorafenib with standard cytotoxic fluoropyrimidine therapy for advanced colorectal cancer may provide clinical benefit when no other treatment remains.

Conditions

Colorectal Cancer Metastatic

Keywords

Metastatic; Colon Cancer; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Sorafenib Activity

  Determine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  2 years

Secondary Outcomes (5)

• Overall Survival

  5 years

• Response Rate

  3 months

• Response Duration

  up to 12 months

• Toxicity (Percentage of Subjects That Experienced an Adverse Event)

  12 months

• Correlative Tissue Analysis

  6 months

Study Arms (1)

Sorafenib Plus Capecitabine (SorCape)

EXPERIMENTAL

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Drug: Sorafenib Plus Capecitabine (SorCape)

Interventions

Sorafenib Plus Capecitabine (SorCape) DRUG

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

Also known as: Nexavar, Xeloda, Chemotherapy

Sorafenib Plus Capecitabine (SorCape)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven adenocarcinoma of the colon or rectum.
• Metastatic disease that is not amenable to potentially curative treatment.
• Measurable disease (as per RECIST 1.1 criteria).
• At least one prior chemotherapeutic regimen for metastatic disease. Patients must have progressed following oxaliplatin based therapy (in either the adjuvant or metastatic setting) and irinotecan based therapy (in the metastatic setting).
• Adequate bone marrow, liver and renal function.
• Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate, provided stability in anticoagulation therapy is documented at the treating provider's discretion. For patients on warfarin, the INR should be measured prior to the initiation of study treatment and should be monitored at least weekly, or as defined by the local standard of care, until INR is stable.
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
• Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
• Patients may have had a history of other (non-colorectal) malignancies if there is no current evidence of persistent or recurrent disease and they are not undergoing any active therapy (including hormonal).
• Patients should have paraffin-embedded tissue from initial diagnosis or prior colorectal cancer surgery available for molecular analysis.
• Patients must consent to participate in the study and must have signed and dated an IRB-approved consent form conforming to federal and institutional guidelines. Consent must be obtained prior to any study specific procedures.

You may not qualify if:

• Prior therapy with a tyrosine kinase inhibitor.
• Age \< 18 years
• ECOG Performance Status \> 2
• Less than 28 days elapsed from prior radiation therapy, surgery or chemotherapy to the time of registration.
• History of known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• History of clinically significant cardiac disease (severe/unstable angina pectoris, NYHA class III or IV congestive heart failure, symptomatic coronary artery disease) or myocardial infarction, cerebrovascular accident or transient ischemic attack within the last 12 months.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Uncontrolled hypertension defined as systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg, as measured on 3 consecutive pre-enrollment assessments, despite optimal medical management.
• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• Active clinically serious infection \> CTCAE Grade 2.
• Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug.
• Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
• Pulmonary embolism or any other uncontrolled thromboembolic event within 3 months prior to registration or occurrence of deep vein thrombosis within 4 weeks of registration.
• Serious non-healing wound, ulcer, or bone fracture.
• Evidence or history of a clinically significant bleeding diathesis or coagulopathy (without vitamin K antagonist therapy).
• Use of St. John's Wort or rifampin (rifampicin).

Sponsors & Collaborators

• University of Florida: lead
• Bayer: collaborator

Study Sites (1)

UF Health Cancer Center

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Sorafenib; Capecitabine; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics

Results Point of Contact

• Title: Dr. Thomas J. George, Jr.
• Organization: University of Florida

thom.george@medicine.ufl.edu

352-273-8008

Study Officials

• Thomas George, MD, FACP

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: May 1, 2017
• Last Updated: July 23, 2020
• Results First Posted: March 30, 2017

Record last verified: 2020-07

Locations

US (1)