Dose Dense Therapy and Bevacizumab in Solid Tumors and Colorectal Cancer
Colorectal Cancer, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring unspecified adult solid tumor, protocol specific, stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Phase I: Histologically or cytologically confirmed solid tumor Metastatic OR locally advanced unresectable disease No curative therapy exists Measurable or evaluable disease Measurable disease is defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques OR ≥ 10 mm with spiral CT scan No known brain metastases Phase II: Histologically or cytologically confirmed colorectal cancer Metastatic OR locally advanced unresectable disease Measurable disease (as defined in phase I) No tumor involving major blood vessels No evidence of CNS disease, including primary brain tumor or brain metastases PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Life expectancy ≥ 12 weeks Absolute neutrophil count (ANC) ≥ 1,500/mm^3 ANC < 1,500/mm^3 allowed, if in the opinion of the investigator, this represents an ethnic or racial variation of normal Platelet count ≥ 100,000/mm^3 Hemoglobin > 10.0 g/dL Bilirubin ≤ 1.5 mg/dL AST/ALT ≤ 2 times upper limit of normal (ULN) Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min Urine protein:creatinine ratio < 1.0 OR protein < 1 g by 24-hour urine collection (phase II) PT/INR ≤ 1.5 unless on full-dose anticoagulants (phase II) Not pregnant or nursing Negative pregnancy test Fertile female patients must use effective double-barrier contraception during and for 28 days (phase I) or 3 months (phase II) after completion of study treatment Fertile male patients must use effective contraception during and for 6 months after completion of study treatment No history of allergic reaction attributed to compounds of similar chemical or biologic composition to capecitabine, irinotecan hydrochloride, oxaliplatin, or bevacizumab No other uncontrolled illness including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness or social situation that would preclude study compliance No cardiac ischemia within the past 6 months (phase I) No New York Heart Association class II-IV congestive heart failure or symptomatic arrhythmia (phase II) No arterial thrombotic events within the past 6 months including, but not limited to, any of the following (phase II): Transient ischemic attack Cerebrovascular accident Unstable angina or angina requiring surgical or medical intervention Myocardial infarction No clinically significant peripheral vascular disease (phase II) No history of hypertension unless well controlled (< 150/90 mm Hg) on an antihypertensive regimen (phase II) No evidence of bleeding diathesis or coagulopathy (phase II) No gastrointestinal (GI) perforation, abdominal fistula, or intra-abdominal abscess within the past 30 days (phase II) No significant history of bleeding events (phase II) Patients with a history of significant bleeding episodes (e.g., hemoptysis or upper or lower GI bleeding) within the past 6 months are not eligible unless the source of bleeding has been resected No significant traumatic injury within the past 28 days (phase II) No serious or nonhealing wound, ulcer, or bone fracture (phase II) No peripheral neuropathy > grade 1 PRIOR CONCURRENT THERAPY: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered (phase I) At least 2 weeks since prior immunotherapy or biologic therapy and recovered (phase I) No prior treatment for advanced or metastatic colorectal cancer (phase II) More than 12 months since prior adjuvant chemotherapy and/or biologic therapy (e.g., bevacizumab or cetuximab) and recovered (phase II) At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to the only site of measurable disease unless there is measurable disease progression within the radiation port after completion of radiotherapy No prior radiotherapy to ≥ 20% of the bone marrow More than 28 days since prior major surgical procedure* or open biopsy and recovered (phase II) More than 14 days since prior minor surgery* and recovered (phase II) Concurrent full-dose anticoagulation (e.g., warfarin) allowed provided the following criteria are met (phase II): Patient has an in-range INR (between 2 and 3) and is on a stable dose of oral anticoagulants or a stable dose of low molecular weight heparin No active bleeding or pathological condition that carries a high risk of bleeding (e.g., known varices) No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No concurrent sargramostim (GM-CSF) NOTE: *Insertion of a vascular device is not considered major or minor surgery
Sites / Locations
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center