Solid Tumor (Adult)
Phase I Study of Vandetanib (ZD 6474) and Bevacizumab Combination Therapy Evaluating the VEGF and EGF Signal Transduction Pathways in Adults With Solid Tumors and Lymphomas
NCI-08-C-0087
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Investigator(s): |
Shivaani Kummar, M.D. Principal Investigator Phone: 301-435-5402 kummars@mail.nih.gov
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Deborah Allen, R.N., O.C.N. Research Nurse Phone: 301-402-5640 Fax: 301-480-7281 allendeb@mail.nih.gov
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Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov
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Primary Eligibility:
- Histologically confirmed solid tumors and lymphoma (Hodgkin’s lymphoma and non-Hodgkin’s lymphoma); no squamous cell or small cell lung carcinoma
- Refractory to standard treatment or for which no standard treatment exists
- Patients with lymphoma may be eligible if disease progressed following standard therapy and if stem cell transplantation is not indicated or has been refused
- No known CNS disease; treated brain metastasis may be allowed
- Prior anti-VEGF therapy allowed
- Recovered from all prior therapies
- ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
- ≥ 18 years of age
- Absolute neutrophil count ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST and ALT ≤ 2.5 x ULN
- Creatinine < 1.5 x ULN OR creatinine clearance ≥ 60 mL/min
- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine collection
- Activated partial thromboplastin time ≤ 1.5 x ULN
- Prothrombin time OR INR < 1.5 x ULN
- Potassium between 4 mmol/L and ULN (supplementation allowed)
- Magnesium normal (supplementation allowed)
- Serum calcium (adjusted for albumin) or ionized calcium normal (supplementation allowed)
- Not pregnant or nursing; fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
- No medical condition that would preclude study participation
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No congenital long QT syndrome, or first-degree relative with unexplained sudden death at < 40 years of age
- No current use of therapeutic anticoagulation medication or history of thromboembolytic disease within the last 6 mos
Treatment Plan:
- Patients receive oral vandetanib once daily on Days 1–21 and bevacizumab IV over 30–90 minutes on Day 1
- Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
- Patients undergo periodic blood sample collection
- Patients may also undergo optional tumor biopsies for additional correlative laboratory studies
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 8/29/08
Updated: 10/31/08