Potential Biomarkers for Bevacizumab-Induced High Blood Pressure in Patients With Solid Tumor
This study has been terminated.
(funding withdrawn due to fellow's departure from VICC)
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01096381
First received: March 30, 2010
Last updated: February 23, 2012
Last verified: February 2012
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Purpose
RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer receiving bevacizumab may help doctors learn more about changes that occur in DNA and identify biomarkers related to high blood pressure.
PURPOSE: This phase I trial is studying potential biomarkers for bevacizumab-induced high blood pressure in patients with malignant solid tumors, including breast cancer, colorectal cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma.
| Condition | Intervention |
|---|---|
|
Breast Cancer Cardiovascular Complications Colorectal Cancer Fallopian Tube Cancer Head and Neck Cancer Lung Cancer Ovarian Cancer Peritoneal Cavity Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Other: laboratory biomarker analysis Other: questionnaire administration |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective Clinical Trial Evaluating Potential Biomarkers for Bevacizumab Induced Hypertension |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Cancer
Colorectal Cancer
Head and Neck Cancer
High Blood Pressure
Lung Cancer
Ovarian Cancer
Drug Information available for:
Bevacizumab
U.S. FDA Resources
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- Digital-pulse amplitude (DPA) measures [ Time Frame: 1, 3 and 6 months after initiation of bevacizumab ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Relationship between hypertension and baseline DPA [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
- Endothelial progenitor cell levels pre- and post-bevacizumab [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
- Correlation between physical fitness level and cardiotoxicity [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 8 |
| Study Start Date: | March 2010 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Will receive bevacizumab |
Other: laboratory biomarker analysis
Blood collection
Other: questionnaire administration
Survey regarding baseline health and activity level.
|
| Will not receive bevacizumab |
Other: laboratory biomarker analysis
Blood collection
Other: questionnaire administration
Survey regarding baseline health and activity level.
|
Detailed Description:
OBJECTIVES:
Primary
- To measure the endothelial function over time, including non-invasive assessment of digital-pulse amplitude via Endo-pat test, serum tPA, PAI-1, VEGF, urine TXa2, and PGI-M, in patients with solid malignancies treated with chemotherapy with or without bevacizumab.
- To compare endothelial function changes between patients who develop hypertension (HTN) versus patients who do not develop HTN.
Secondary
- To compare circulating soluble cytokines, proangiogenic factors, glucose tolerance, and cardiac biomarkers over time in these patients.
- To compare endothelial progenitor cell levels pre- and post-bevacizumab in these patients.
- To assess whether physical fitness level at baseline and at 3 months after treatment initiation (assessed subjectively by questionnaire) correlates with relative risk of developing NCI grade ≥ I cardiotoxicity.
OUTLINE: Patients undergo 24-hour blood pressure monitoring at baseline, before second bevacizumab therapy, and periodically during study. Patients also undergo a digital-pulse amplitude measurement periodically during study.
Blood samples are collected at baseline and periodically during study for circulating soluble cytokines, proangiogenic factors, glucose tolerance, cardiac biomarkers, and endothelial progenitor cell level studies. Patients also undergo 24-hour urine sample collection at baseline and periodically during study for protein, creatinine, and metabolites of prostacyclin and thromboxane.
Patients complete physical activity questionnaires at baseline and at 3 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with stage IV breast, colorectal, or non-small cell lung cancer (NSCLC) who will get bevacizumab as a standard of care, as well as patients with breast, colorectal, ovarian/fallopian tube/peritoneal, head and neck, or NSCLC cancer about to initiate bevacizumab. Where possible, the study population will include a control group not receiving bevacizumab.
Criteria
Inclusion Criteria:
Patients with stage IV or unresectable recurrent cancer (except for renal cell carcinoma and glioblastoma multiforme) that will get bevacizumab as a standard of care, as well as patients about to initiate bevacizumab within the protocols:
- ECOG5103: A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer.
- ECOG1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)
- ECOG5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
- ECOG1305: Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer
- GOG0252: A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
- GOG0086P: A Three Arm Randomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab, Paclitaxel/Carboplatin/Temsirolimus, and Ixabepilone/Carboplatin/Bevacizumab as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer (Only those arms including bevacizumab)
- GOG0250: A Randomized Phase III Evaluation of Docetaxel and Gemcitabine Plus G-CSF with Bevacizumab Versus Docetaxel and Gemcitabine Plus G-CSF with Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
- GOG0240: A Randomized Phase III Evaluation of Docetaxel and Gemcitabine Plus G-CSF with Bevacizumab Versus Docetaxel and Gemcitabine Plus G-CSF with Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
- THO0640: A Phase II Multi Center Study Investigating Translational Science in Chemotherapy-Naïve Patients with Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) treated with the EGFR-TKI, Erlotinib (SPECS)
Eligibility Criteria:
- Patients ≥ 18 years of age with stage IV or unresectable recurrent cancer (except for renal cell carcinoma and glioblastoma multiforme) that will get bevacizumab as a standard of care.
- Patients ≥ 18 years of age with histologically confirmed breast, colorectal or non-small cell lung (NSCL) cancer that have completed surgical treatment for stages I - III cancer and are going to initiate adjuvant therapy within one of the 3 clinical trials addressing the role of bevacizumab added to chemotherapy in the adjuvant setting of breast, colorectal and NSCL cancer (E5103, E1505 and E5202)
- Patients ≥ 18 years of age with histologically confirmed squamous cell carcinoma of the head and neck (recurrent or metastatic) who are about to initiate chemotherapy with or without bevacizumab within E1305 clinical trial.
- Patients ≥ 18 years of age who are about to initiate chemotherapy with bevacizumab within the following trials: GOG0252, GOG0086P (only those patients receiving bevacizumab arms), GOG0250, and GOG0240.
- Patients ≥ 18 years of age with a histologic diagnosis of non small cell lung cancer who are about to initiate bevacizumab within THO0640 clinical trial.
- Patients must provide informed written consent.
Ineligibility Criteria
- Patients with active renal cell carcinoma or glioblastoma multiforme
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096381
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Principal Investigator: | Ingrid Mayer, M.D. | Vanderbilt-Ingram Cancer Center |
| Principal Investigator: | Ingrid Mayer, MD | Vanderbilt-Ingram Cancer Center |
More Information
No publications provided
| Responsible Party: | Ingrid Mayer, MD, Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01096381 History of Changes |
| Other Study ID Numbers: | VICC BRE 0983, P30CA068485, VU-VICC-BRE-0983 |
| Study First Received: | March 30, 2010 |
| Last Updated: | February 23, 2012 |
| Health Authority: | United States: Vanderbilt University Human Research Protection Program |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
cardiovascular complications stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer stage I rectal cancer stage II rectal cancer stage III rectal cancer stage IV rectal cancer |
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer unspecified adult solid tumor, protocol specific recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent adenoid cystic carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent verrucous carcinoma of the oral cavity |
Additional relevant MeSH terms:
|
Breast Neoplasms Colorectal Neoplasms Head and Neck Neoplasms Hypertension Lung Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Vascular Diseases Cardiovascular Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013