Ziv-Aflibercept Followed by Ziv-Aflibercept, Fluorouracil, and Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

In brief

This phase II trial studies how long it takes colorectal cancer resistant to standard treatment to grow while receiving treatment with ziv-aflibercept, and how well adding fluorouracil and leucovorin calcium to ziv-aflibercept works in treating patients with stage IV colorectal cancer after they progress on ziv-aflibercept alone. Ziv-aflibercept may stop the growth of colorectal cancer by blocking the formation of tumor blood vessels. Fluorouracil and leucovorin calcium are drugs used in chemotherapy. Fluorouracil works to stop the growth of tumors cells by preventing the cells from growing and dividing. Leucovorin calcium helps fluorouracil work better. Adding fluorouracil and leucovorin calcium to ziv-aflibercept may be an effective treatment for patients who progress on ziv-aflibercept alone.

Key facts

Study ID: NCT02235324
Run by: University of Southern California
People needed: 0
Starts: 2015-03-01
Expected to finish: 2018-03-01
Last updated by the study team: 2015-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed stage IV colorectal adenocarcinoma previously treated with FOLFOX and FOLFIRI and bevacizumab, receipt of cetuximab or panitumumab is not required, and has shown progression or intolerant of both oxaliplatin and irinotecan-based regimens; baseline tumor assessments must be done within 28 days of starting treatment
Patients must have lesions that can be easily biopsied
Representative tumor tissue specimens (paraffin block preferred)
Signed informed consent prior to initiation of any study-specific procedure or treatment, including agreement to two biopsies during the study
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Able to comply with the protocol, including tissue and blood sampling
Leukocytes >= 3,000 per mm\^3
Absolute neutrophil count >= 1,000 per mm\^3
Platelet count >= 75,000 per mm\^3
Hemoglobin >= 9 g/dL (may be transfused to maintain or exceed this level)
Creatinine clearance according to the Cockcroft and Gault formula of >= 50 mL/min
Urine for proteinuria should be < 2 +; patients discovered to have >= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate < 1 g of protein in 24 hours
Total bilirubin < 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase and alanine aminotransferase < 2.5 x ULN
International normalized ratio =< 1.5 and activated prothrombin time =< 1.5 x ULN for patients not receiving anti-coagulation therapy
The use of full-dose oral or parenteral anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard of the enrolling institution), and the patient has been on a stable dose of anticoagulants for at least two weeks prior to the first study treatment
Female patients should not be pregnant or breast-feeding
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 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 months)
Female patients with childbearing potential should agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of at least 6 months following the last administration of study drug
Female patients with an intact uterus (unless amenorrheic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the study
Male patients must agree to use effective contraception during the study and for a period of at least 6 months following the last administration of study drugs, even if they have been surgically sterilized

You may not qualify if…

Any prior systemic treatment with targeted antiangiogenic agents except for bevacizumab; receipt of cetuximab or panitumumab is not an exclusion criteria
Radiotherapy to any site for any reason within 14 days prior to treatment
Uncontrolled intercurrent illness including, but not limited to
Any of the following within 6 months prior to inclusion: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack
Any of the following within 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding/hemorrhage (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event
History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study
History of arterial thromboembolic events
History of abdominal fistula formation, gastrointestinal perforation, or abdominal abscess within six months
History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding
Patients must not be pregnant or nursing
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
Any hemorrhage or bleeding event >= CTCAE grade 3 within 4 weeks prior to the start of study medication
Non-healing wound, ulcer, or bone fracture
Inadequately controlled hypertension (systolic blood pressure [SBP] > 150 mmHg, diastolic blood pressure [DBP] > 100 mg Hg)
Known positivity for human immunodeficiency virus (HIV)
Malignancies other than colorectal adenocarcinoma within 5 years prior to treatment, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
Clinically detectable (by physical exam) third-space fluid collections (e.g. ascites or pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry
Treatment with any other investigational agent, or participation in another investigational drug trial within 28 days prior to randomization
Patients can withdraw consent anytime during the study

Where it is running

USC Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.