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
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 4 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.)
3.1 Inclusion Criteria
3.1.1 Biopsy-proven invasive adenocarcinoma of the rectum, stage T3-4 and/or node-positive (AJCC stage II or III), patients with AJCC 7th edition, M1a cancer (
* metastasis confined to one organ or site [ e.g., liver, lung, ovary, non regional node]
* ), stage IVA disease, are also eligible. For the purpose of this study, a tumor is located in the
* 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.
3.1.3 Age > 18 years.
3.1.4 Performance status of 0 or 1 on the ECOG scale is required (See Appendix 1).
3.1.5 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
-No additional screening intended for HIV or hepatitis infection
3.1.6 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.
22.214.171.124 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).
3.1.7 Ability to understand and the willingness to sign a written informed consent. patients with tumors < or =12cm from the anal verge are eligible