Hydroxychloroquine, Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2016-04-27
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Hydroxychloroquine may help chemotherapy and bevacizumab work better and kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving hydroxychloroquine together with capecitabine, oxaliplatin, and bevacizumab works in treating patients with metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Capecitabine; Hydroxychloroquine; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed colorectal carcinoma

• Metastatic disease

• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as > 20 mm by conventional techniques or > 10 mm by spiral CT scan

• Brain metastases allowed provided they have been treated and stable for > 4 weeks

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 12 weeks

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• AST/ALT ≤ 3 times upper limit of normal (ULN)

• Total bilirubin ≤ 1.5 times ULN

• PT (INR) ≤ 1.5

• Creatinine < 1.5 times ULN

• Creatinine clearance ≥ 30 mL/min

• Urine protein:creatinine ratio < 1.0 OR < 1 g protein by 24-hour urine collection

• Not on dialysis

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment

• Prior non-colonic malignancies allowed provided there is no current clinical evidence of persistent or recurrent disease AND the patient is not on active therapy, including hormonal therapy

• No uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg, despite antihypertensive medications

• No cardiac disease, including any of the following:

• NYHA class III-IV congestive heart failure

• Unstable angina (anginal symptoms at rest)

• New onset angina (began within the past 3 months)

• Myocardial infarction within the past 6 months

• Uncontrolled arrhythmia

• No thrombolic or embolic events (e.g., cerebrovascular accident including transient ischemic attacks) within the past 6 months

• No serious non-healing wound, ulcer, or bone fracture

• No significant traumatic injury within the past 28 days

• No neuropathy ≥ grade 2

• No evidence of bleeding diathesis or coagulopathy

• No condition that would impair the patient's ability to swallow whole pills

• No malabsorption problem

• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

• No known G-6PD deficiency

• No retinal or visual field changes from prior 4-aminoquinoline compound use

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine or hydroxychloroquine

• No other concurrent serious systemic disorders (including active infections) that, in the investigator's opinion, would compromise the safety of the patient or compromise the patient's ability to complete the study

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy for metastatic disease, except for adjuvant therapy that was completed ≥ 6 months before the first evidence of metastasis

• More than 28 days since prior major surgical procedure or open biopsy

• No concurrent anticoagulation with warfarin

• Concurrent low molecular weight heparin (or an equivalent drug) allowed

• No concurrent hydroxychloroquine for treatment or prophylaxis of malaria

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent St. John wort

• No other concurrent investigational or anticancer agents or therapies