Erlotinib and Avastin in Patients With Cancer of the Esophagus or Gastroesophageal Junction
NCT ID: NCT00442507
Last Updated: 2015-07-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2007-03-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
Erlotinib
Avastin
Interventions
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Erlotinib
Avastin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic or advanced inoperable disease previously treated with one prior chemotherapy regimen
* Age greater than 18 years.
* Performance status ECOG 0 to 1.
* Adequate hepatic and renal function, defined as:
* Serum creatinine \<= 3.0 mg/dL;
* Creatinine clearance \>= 45 mL/min.
* Bilirubin \<= 1.5 x institutional normal;
* ALT/AST \<= 3 x institutional normal.
* Patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension. The longest diameter of measurable lesions must be \>= 20 mm with conventional techniques or \>= 10 mm with spiral CT scan. Lesions that are not considered measurable include: bone lesions, leptomeningeal disease, brain lesions, ascites, pericardial or pleural effusion, and tumors situated in a previously irradiated area.
* Use of effective means of contraception for both male and female patients with child-bearing potential.
* A 1 month wash-out period is required for all patients entering this study from a previous treatment regimen
Exclusion Criteria
* Previous history of cancer. The patient with a prior malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patients have been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0; or anticipation of the need for major surgical procedure during the course of the study. (In the case of high risk procedures such as liver resection, thoracotomy, or neurosurgery, it is recommended that patient delay treatment with chemotherapy for at least 6 weeks and with bevacizumab at least 8 weeks after surgery).
* Radiation therapy within the last 2 weeks.
* Presence of central nervous system or brain metastases at any time.
* Serious, non-healing wound, ulcer, or bone fracture
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0; and/or minor surgical procedures such as fine needle aspiration or core biopsies within 7 days prior to day 0.
* Presence of coagulopathy or clinical history of significant hematemesis, melena, or hemoptysis related to the diagnosis of esophageal cancer.
* Previous history of deep venous thrombosis or thromboembolic disease.
* Urine protein/urine creatinine ratio ≥ 1.0 at screening.
* Pregnant or lactating.
* Unstable angina or history of myocardial infarction within the last 6 months.
* History of stroke within the last 6 months.
* Uncontrolled hypertension with blood pressure persistently \> 150/100 mmHg despite optimal antihypertensive therapy.
* Clinically significant peripheral vascular disease.
* Congestive heart failure with New York Heart Association grades III or IV (see appendix B).
* Inability to complete the study and follow-up procedures.
* Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to enrollment
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Daniel Morgensztern, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Shah MA, Schwartz GK. Treatment of metastatic esophagus and gastric cancer. Semin Oncol. 2004 Aug;31(4):574-87. doi: 10.1053/j.seminoncol.2004.04.013.
Heath EI, Urba S, Marshall J, Piantadosi S, Forastiere AA. Phase II trial of docetaxel chemotherapy in patients with incurable adenocarcinoma of the esophagus. Invest New Drugs. 2002 Feb;20(1):95-9. doi: 10.1023/a:1014476602804.
Conroy T, Etienne PL, Adenis A, Wagener DJ, Paillot B, Francois E, Bedenne L, Jacob JH, Seitz JF, Bleiberg H, Van Pottelsberghe C, Van Glabbeke M, Delgado FM, Merle S, Wils J. Phase II trial of vinorelbine in metastatic squamous cell esophageal carcinoma. European Organization for Research and Treatment of Cancer Gastrointestinal Treat Cancer Cooperative Group. J Clin Oncol. 1996 Jan;14(1):164-70. doi: 10.1200/JCO.1996.14.1.164.
Lordick F, von Schilling C, Bernhard H, Hennig M, Bredenkamp R, Peschel C. Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer. Br J Cancer. 2003 Aug 18;89(4):630-3. doi: 10.1038/sj.bjc.6601168.
Mendelsohn J, Baselga J. Status of epidermal growth factor receptor antagonists in the biology and treatment of cancer. J Clin Oncol. 2003 Jul 15;21(14):2787-99. doi: 10.1200/JCO.2003.01.504.
Baselga J, Arteaga CL. Critical update and emerging trends in epidermal growth factor receptor targeting in cancer. J Clin Oncol. 2005 Apr 10;23(11):2445-59. doi: 10.1200/JCO.2005.11.890. Epub 2005 Mar 7.
Johnson JR, Cohen M, Sridhara R, Chen YF, Williams GM, Duan J, Gobburu J, Booth B, Benson K, Leighton J, Hsieh LS, Chidambaram N, Zimmerman P, Pazdur R. Approval summary for erlotinib for treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Clin Cancer Res. 2005 Sep 15;11(18):6414-21. doi: 10.1158/1078-0432.CCR-05-0790.
Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
Folkman J. Tumor angiogenesis: therapeutic implications. N Engl J Med. 1971 Nov 18;285(21):1182-6. doi: 10.1056/NEJM197111182852108. No abstract available.
Folkman J. What is the evidence that tumors are angiogenesis dependent? J Natl Cancer Inst. 1990 Jan 3;82(1):4-6. doi: 10.1093/jnci/82.1.4. No abstract available.
Ferrara N, Keyt B. Vascular endothelial growth factor: basic biology and clinical implications. EXS. 1997;79:209-32. doi: 10.1007/978-3-0348-9006-9_9. No abstract available.
Borgstrom P, Gold DP, Hillan KJ, Ferrara N. Importance of VEGF for breast cancer angiogenesis in vivo: implications from intravital microscopy of combination treatments with an anti-VEGF neutralizing monoclonal antibody and doxorubicin. Anticancer Res. 1999 Sep-Oct;19(5B):4203-14.
Presta LG, Chen H, O'Connor SJ, Chisholm V, Meng YG, Krummen L, Winkler M, Ferrara N. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res. 1997 Oct 15;57(20):4593-9.
Petit AM, Rak J, Hung MC, Rockwell P, Goldstein N, Fendly B, Kerbel RS. Neutralizing antibodies against epidermal growth factor and ErbB-2/neu receptor tyrosine kinases down-regulate vascular endothelial growth factor production by tumor cells in vitro and in vivo: angiogenic implications for signal transduction therapy of solid tumors. Am J Pathol. 1997 Dec;151(6):1523-30.
Hirata A, Ogawa S, Kometani T, Kuwano T, Naito S, Kuwano M, Ono M. ZD1839 (Iressa) induces antiangiogenic effects through inhibition of epidermal growth factor receptor tyrosine kinase. Cancer Res. 2002 May 1;62(9):2554-60.
Ciardiello F, Caputo R, Damiano V, Caputo R, Troiani T, Vitagliano D, Carlomagno F, Veneziani BM, Fontanini G, Bianco AR, Tortora G. Antitumor effects of ZD6474, a small molecule vascular endothelial growth factor receptor tyrosine kinase inhibitor, with additional activity against epidermal growth factor receptor tyrosine kinase. Clin Cancer Res. 2003 Apr;9(4):1546-56.
Jung YD, Mansfield PF, Akagi M, Takeda A, Liu W, Bucana CD, Hicklin DJ, Ellis LM. Effects of combination anti-vascular endothelial growth factor receptor and anti-epidermal growth factor receptor therapies on the growth of gastric cancer in a nude mouse model. Eur J Cancer. 2002 May;38(8):1133-40. doi: 10.1016/s0959-8049(02)00013-8.
Shaheen RM, Ahmad SA, Liu W, Reinmuth N, Jung YD, Tseng WW, Drazan KE, Bucana CD, Hicklin DJ, Ellis LM. Inhibited growth of colon cancer carcinomatosis by antibodies to vascular endothelial and epidermal growth factor receptors. Br J Cancer. 2001 Aug 17;85(4):584-9. doi: 10.1054/bjoc.2001.1936.
Tew WP, Kelsen DP, Ilson DH. Targeted therapies for esophageal cancer. Oncologist. 2005 Sep;10(8):590-601. doi: 10.1634/theoncologist.10-8-590.
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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06-1105
Identifier Type: -
Identifier Source: org_study_id
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