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A Prospective Clinical Trial Evaluating Potential Biomarkers for Bevacizumab Induced Hypertension


N/A
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

A Prospective Clinical Trial Evaluating Potential Biomarkers for Bevacizumab Induced Hypertension


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Digital-pulse amplitude (DPA) measures

Outcome Time Frame:

1, 3 and 6 months after initiation of bevacizumab

Safety Issue:

No

Principal Investigator

Ingrid Mayer, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Vanderbilt University Human Research Protection Program

Study ID:

VICC BRE 0983

NCT ID:

NCT01096381

Start Date:

March 2010

Completion Date:

August 2011

Related Keywords:

  • 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
  • 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
  • stage IV adenoid cystic carcinoma of the oral cavity
  • stage IV mucoepidermoid carcinoma of the oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • recurrent basal cell carcinoma of the lip
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV basal cell carcinoma of the lip
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • recurrent metastatic squamous neck cancer with occult primary
  • untreated metastatic squamous neck cancer with occult primary
  • recurrent lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Hypertension
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064