Status:
TERMINATED
Dose Dense Therapy and Bevacizumab in Solid Tumors and Colorectal Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from...
Detailed Description
The study was originally intended to be Phase I/Phase II but it was terminated early because of toxicity of treatment and therefore never moved to the Phase II portion of the study. OBJECTIVES: * De...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00296062
Start Date
March 1 2006
End Date
May 1 2011
Last Update
January 16 2012
Active Locations (1)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065