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A Phase I Study of the Phosphatidylserine-Targeting Antibody Bavituximab in Combination With Capecitabine and Radiation Therapy for the Treatment of Stage II and III Rectal Adenocarcinoma

Phase 1
18 Years
Open (Enrolling)
Stage II and III Rectal Adenocarcinoma

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Trial Information

A Phase I Study of the Phosphatidylserine-Targeting Antibody Bavituximab in Combination With Capecitabine and Radiation Therapy for the Treatment of Stage II and III Rectal Adenocarcinoma

Inclusion Criteria:

- 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).

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or

- Bleeding

1. Clinically significant bleeding, such as gross hematuria, gastrointestinal
bleeding (excluding bleeding from rectal tumor), and hemoptysis within the 12
months before screening. If clinically significant bleeding has occurred within
12 months of screening but the cause has been identified and adequately treated
(e.g., cystitis, ulcer), then this exclusion criterion does not apply.

2. 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

- 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.

- Subjects receiving other investigational agents thirty days prior to study treatment
or during treatment.

- History of inflammatory bowel disease

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

dose-limiting toxicities (DLT)

Outcome Description:

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

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Jeffrey Meyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center


United States: Food and Drug Administration

Study ID:

STU 032012-025



Start Date:

August 2012

Completion Date:

June 2016

Related Keywords:

  • Stage II and III Rectal Adenocarcinoma
  • Rectal cancer
  • Bavituximab
  • Capecitabine
  • Radiation Therapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms



University of Texas Southwestern Medical CenterDallas, Texas