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Trial record 13 of 21 for:    bavituximab

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01634685
First received: June 28, 2012
Last updated: February 29, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Rectal Adenocarcinoma
Radiation: Radiation
Drug: Bavituximab
Drug: Capecitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • dose-limiting toxicities (DLT) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    To determine dose-limiting toxicities (DLT) for bavituximab when administered on a weekly basis concurrently with external beam radiation therapy.


Secondary Outcome Measures:
  • adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To describe the adverse events associated with bavituximab when administered on a weekly basis concurrently with external beam irradiation and capecitabine

  • MR imaging and histopathological response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To describe any preliminary evidence of anti-tumor activity by assessment of objective response as determined by MR imaging and histopathological response in patients with T3-4 and/or node-positive rectal adenocarcinoma.

  • tumor-vasculature parameters [ Time Frame: week 3 and 12 ] [ Designated as safety issue: No ]
    To determine if the combination of bavituximab, capecitabine, and radiation therapy induces changes in tumor-vasculature parameters as assessed by DCE-MRI, in selected patients.

  • maximally tolerated dose (MTD) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    To determine maximally tolerated dose (MTD) for bavituximab when administered on a weekly basis concurrently with external beam radiation therapy.


Estimated Enrollment: 18
Study Start Date: August 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bavituximab, Capecitabine, Radiation
one arm
Radiation: Radiation
Radiation therapy will be administered daily, Monday-Friday, for a total of 28 treatments, delivered at 1.8 Gy/fraction.
Drug: Bavituximab
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.
Other Name: Phosphatidylserine-Targeting Antibody
Drug: Capecitabine
capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2.
Other Name: Xeloda

Detailed Description:
The investigational drug in this protocol is bavituximab, which will be delivered concurrently with the radiation therapy for 6 weeks (one time each week), followed by 2 weeks of bavituximab administration by itself. If the other therapies are terminated after week 4 the bavituximab treatment may be continued per protocol. A chemotherapy agent, capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2. Radiation therapy will be administered daily, Monday-Friday, for a total of 28 treatments, delivered at 1.8 Gy/fraction. Surgery will follow the last bavituximab administration by 4-8 weeks (6-10 weeks following completion of radiation therapy.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 hemophilia).
  • 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 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.
  • Subjects receiving other investigational agents thirty days prior to study treatment or during treatment.
  • History of inflammatory bowel disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01634685

Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jeffrey Meyer, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01634685     History of Changes
Other Study ID Numbers: STU 032012-025 
Study First Received: June 28, 2012
Last Updated: February 29, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Texas Southwestern Medical Center:
Rectal cancer
Bavituximab
Capecitabine
Radiation Therapy

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antibodies
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 06, 2016