A Phase I Study of Bavituximab, Capecitabine, and Radiation for the Treatment of Rectal Adenocarcinoma

NCT01634685 | Completed Phase 1 DMC

• 1 other identifier: STU 032012-025
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study incorporating bavituximab into the care of patients with rectal adenocarcinoma simultaneously treated with capecitabine and radiation therapy. There is no reference therapy as we are trying to identify the MTD of bavituximab in this combination.

Conditions

Rectal Adenocarcinoma

Keywords

Rectal cancer; Bavituximab; Capecitabine; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• dose-limiting toxicities (DLT)

  To determine dose-limiting toxicities (DLT) for bavituximab when administered on a weekly basis concurrently with external beam radiation therapy.

  28 days

Secondary Outcomes (4)

• adverse events

  12 weeks

• MR imaging and histopathological response

  12 weeks

• tumor-vasculature parameters

  week 3 and 12

• maximally tolerated dose (MTD)

  28 days

Study Arms (1)

Bavituximab, Capecitabine, Radiation

EXPERIMENTAL

one arm

Radiation: Radiation; Drug: Bavituximab; Drug: Capecitabine

Interventions

Radiation RADIATION

Radiation therapy will be administered daily, Monday-Friday, for a total of 28 treatments, delivered at 1.8 Gy/fraction.

Bavituximab, Capecitabine, Radiation

Bavituximab DRUG

Bavituximab will be delivered concurrently with the radiation therapy for 6 weeks (one time each week), followed by 2 weeks of bavituximab administration by itself.

Also known as: Phosphatidylserine-Targeting Antibody

Bavituximab, Capecitabine, Radiation

Capecitabine DRUG

capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2.

Also known as: Xeloda

Bavituximab, Capecitabine, Radiation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven invasive adenocarcinoma of the rectum, stage T3-4 and/or node-positive (AJCC stage II or III). For the purpose of this study, a tumor is located in the "rectum" when its distal edge is located within 12cm of the anal verge. The distal edge of the tumor can be delineated by digital examination or endoscopic examination, including colonoscopy, although rigid proctoscopy is preferred.
• Age \> 18 years.
• Performance status of 0 or 1 on the ECOG scale is required (See Appendix 1).
• Adequate organ and marrow function as defined below:
• leukocytes ≥ 3,000/mcL
• absolute neutrophil count ≥ 1,500/mcL
• platelets ≥ 100,000/mcl
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
• creatinine \<1.5 X institutional upper limits of normal
• aPTT ≤1.5 X institutional upper limits of normal
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy;
• or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

You may not qualify if:

• Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia).
• Bleeding
• Minor biopsy-related bleeding lasting \< 24 hours and resolved at least 1 week before Study Day 1 is allowed.
• Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism) within 6 months of screening.
• Ongoing therapy with oral or parenteral anticoagulants; low-dose anticoagulation to maintain patency of lines is allowed.
• Concurrent estrogens, anti-estrogens or progesterone compounds.
• Any prior radiation for rectal cancer.
• Symptomatic or clinically active brain metastases.
• Major surgery within 4 weeks of Study Day 1.
• Pregnant or nursing women.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of blood clotting abnormalities, or psychiatric illness/social situations that would limit compliance with study requirements.
• Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of screening.
• Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
• Known hypersensitivity to any components of the treatments.
• History of malignancy other than non-melanoma skin cancers within 5 years prior to study enrollment.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiation; bavituximab; Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 6, 2012
• Study Start: August 8, 2012
• Primary Completion: October 30, 2015
• Study Completion: October 6, 2017
• Last Updated: August 20, 2020

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)