Cancer
Conditions
Brief summary
The purpose of this study is to find out if postoperative chemotherapy in patients with high-grade appendix cancer after surgery improves outcomes. The postoperative chemotherapy will consist of 5-FU (with leucovorin) or capecitabine with bevacizumab. These drugs are approved for use in people with colon cancer, and they are used at UCSD for some patients with appendix cancer. The purpose of this study is to explore the safety and efficacy of the postoperative chemotherapy treatment on cancer.
Detailed description
This is an observational, single-cohort, prospective study of systemic chemotherapy after CRS/HIPEC. Subjects will be given twelve months of 5-FU or capecitabine with bevacizumab starting 4-16 weeks after surgery. CTRI Biostatistics Core personnel will assist in conducting analyses using the latest version of R (R Foundation for Statistical Computing, Vienna, Austria. http://www.R-project.org/). No therapy is included in this study. Subjects have already previously undergone surgery for their cancer. This study will observe the outcomes of the postoperative chemotherapy treatment the doctor chooses to treat the subject's cancer.
Interventions
DRUGsystemic chemotherapy
twelve months of 5-FU or capecitabine with bevacizumab starting 4-8 weeks after surgery
Sponsors
University of California, San Diego
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
3.1 Inclusion Criteria Patients must meet all of the inclusion criteria to participate in this study. 1. Ability to understand and the willingness to sign a written informed consent. 2. High-grade peritoneal carcinomatosis from appendiceal adenocarcinoma. 1. Moderate or poorly-differentiated adenocarcinoma, signet ring cell carcinoma or high-grade carcinoma (in primary tumor or extra-appendiceal metastases) as designated by standardized pathologic testing.23,24 2. May be initially determined from pre-CRS/HIPEC tumor pathology (for screening purposes), but must be confirmed with pathology from resected tumors as part of CRS/HIPEC. 3. Have had complete (CC-0 or CC-1) CRS with HIPEC open or minimally invasive (laparoscopic or robotic) 4. Have received or plan to receive 12 months of postoperative chemotherapy, starting no sooner than 4 weeks and no longer than 16 weeks after CRS/HIPEC, consisting of: 1. 5-fluorouracil (Adrucil®) 400 mg/m2 IV bolus then 2400 mg/m2 IV continuous infusion x 46hrs, leucovorin (Leucovorin Calcium) 20 mg/m2 IV bolus and bevacizumab (Avastin®) 5 mg/kg IV every two weeks for a total of 12 months (26 cycles); OR 2. Capecitabine (Xeloda®) 1250 mg/m2 PO twice daily for 14 days, with 7-day break, bevacizumab (Avastin®) 7.5 mg/kg IV every three weeks, for a total of 12 months (17 cycles). 5. Have received or plan to receive standard clinical, biochemical and radiographic surveillance, consisting of: 1. Adverse event assessments every chemotherapy cycle and at the end of treatment 2. CEA, CA19-9 and CA 125 i) Every 1 month x 1 year (during treatment), then ii) Every 1 month x 6 months, then iii) Every 3 months x 1.5 years, then iv) Every 6 months x 1 year c) CT chest, abdomen and pelvis or MRI i) Every 3 months x 1 year (during treatment), then ii) Every 3 months x 1 year, then iii) Every 6 months x 1 year, then iv) Every 12 months x 1 year 6. Age \> 18 years old 7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 (Appendix A). 8. Adequate organ and bone marrow function as defined below: 1. Absolute Neutrophil Count ≥ 1.5 x 109/L 2. Platelet count ≥ 100 x 109/L 3. Hemoglobin ≥ 9.0 g/dL 4. Total bilirubin ≤ 1.5 x ULN 5. AST/SGOT and ALT/SPGT ≤ 2.5 X ULN 6. Serum creatinine ≤ 1.5 x ULN 9. Women of child-bearing potential and men with partners of child-bearing potential 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. a) A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: i) Has not undergone a hysterectomy or bilateral oophorectomy; or ii) 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) 10. Women of child-bearing potential must have negative pregnancy test prior to initiating study drug treatment. 3.2
Exclusion criteria
Subjects meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | 4 years | PFS will be measured from the time of the start of postoperative chemotherapy until disease progression or death during the total study period (four years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 4 years | OS will be measured from the time of the start of postoperative chemotherapy until death during the total study period (four years) |
| Safety and Feasibility | Safety and feasibility of the chemotherapy regimen will be measured from the time of the start of postoperative chemotherapy until completion of chemotherapy (one year) | Safety and feasibility of the chemotherapy regimen will be measured from the time of the start of postoperative chemotherapy until completion of chemotherapy (one year) |
| Quality of life will be measured by the Functional Assessment of Cancer Therapy | Quality of life will be measured from prior to surgery until study completion (four years) | Quality of life will be measured by the Functional Assessment of Cancer Therapy, Colorectal Symptom Index (FCSI). |
Countries
United States
Outcome results
None listed