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BRIEF TITLE: Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)

Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)


  • Org Study ID: Pro00052149
  • Secondary ID:
  • NCT ID: NCT02080650
  • NCT Alias:
  • Sponsor: Duke University - Other
  • Source: Duke University

Brief Summary

This pilot study will aim to determine whether circulating tumor cells (CTCs) can be captured using the novel cMET based ferrofluid. The primary objective of this pilot study will be to describe the numbers of c-MET expressing cells that can be detected by the c-MET CTC capture technique. These data will be separated by disease site. The investigator will also describe the detection rates of both the c-MET CTC capture and the EpCAM CTC capture techniques in each patient, also separated by disease site.

Overal Status Start Date Phase Study Type
Recruiting Start Date: March 2014 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Feasibility

Primary Outcome 1 - Time Frame: day 1

Condition:

  • Prostate Cancer
  • Renal Cell Carcinoma
  • Bladder Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Non-small Cell Lung Cancer
  • Advanced MET Amplified Solid Tumor

Eligibility

Criteria:
Inclusion Criteria:

Prostate cancer patients will be eligible for inclusion in this study only if all of the
following criteria apply:

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or
neuroendocrine tumors of the prostate are also permitted.

2. Clinical or radiographic evidence of metastatic disease.

3. Castrate levels of testosterone (<50 ng/dl)

4. Enrollment prior to the initiation of a new systemic therapy.

5. Evidence of disease progression on or following most recent therapy as evidenced by
either of the following:

- Two consecutive PSA levels greater than the PSA nadir achieved on ADT and most
recent therapy, separated by greater than one week

- Radiographic evidence of disease progression as defined by new bone scan lesions
or growth of soft tissue/visceral metastases >1 cm in diameter (2 cm for lymph
nodes).

- Clinical progression of disease with cutaneous lesions or palpable lesions in
absence of radiographic progression

6. Age > 18 years.

7. Ability to understand and the willingness to sign a written informed consent document.

Renal cell carcinoma patients will be eligible for inclusion in this study only if all of
the following inclusion criteria apply:

1. Histologically confirmed diagnosis of invasive renal cell carcinoma (all histologies)

2. Clinical or radiographic evidence of metastatic disease.

3. Evidence of disease progression on the current or following the most recent therapy,
as defined by one of the following:

- A new soft tissue/visceral/lymph node/bone metastatic lesion

- Growth of existing soft tissue/visceral/lymph node/bone metastases as determined
by the investigator

- Clinical progression of disease with cutaneous lesions or palpable lesions in
absence of radiographic progression

4. For clear cell carcinoma, refractory to treatment with VEGF inhibitors as defined by
progression on VEGF therapy within 1 year of starting VEGF therapy. For non-clear cell
histologies, any line of systemic therapy.

5. Enrollment prior to the initiation of a new systemic therapy.

6. Age > 18 years.

7. Ability to understand and the willingness to sign a written informed consent document.

Bladder cancer patients will be eligible for inclusion in this study only if all of the
following inclusion criteria apply:

1. Histologically confirmed diagnosis of invasive bladder transitional cell carcinoma,
adenocarcinoma, squamous cell carcinoma, or small cell carcinoma.

2. Metastatic disease with either bone or visceral metastatic lesions, or clinically
symptomatic with metastatic disease.

3. Progression of disease on or following the most recent treatment as evidenced by one
of the following:

- A new soft tissue/visceral/lymph node/bone metastatic lesion

- Growth of existing soft tissue/visceral/lymph node/bone metastases as determined
by the investigator.

- Clinical progression of disease with cutaneous lesions, palpable lesions, pleural
effusions, or ascites in absence of radiographic progression

4. Enrollment prior to the initiation of a new systemic therapy.

5. Age > 18 years.

6. Ability to understand and the willingness to sign a written informed consent document.

Gastric cancer (including gastroesophageal junction) patients will be eligible for
inclusion in this study only if all of the following inclusion criteria apply:

1. Histologically confirmed diagnosis of invasive gastric or distal esophageal
adenocarcinoma.

2. Clinical or radiographic evidence of metastatic disease.

3. Evidence of disease progression on or following the most recent therapy, as defined by
one of the following:

- New soft tissue/visceral/lymph node/bone metastatic lesion

- Growth of existing soft tissue/visceral/lymph node/bone metastases as determined
by the investigator

- Clinical progression of disease with cutaneous lesions, palpable lesions, pleural
effusions, or ascites in absence of radiographic progression

4. Enrollment prior to the initiation of a new systemic therapy.

5. Age > 18 years.

6. Ability to understand and the willingness to sign a written informed consent document.

Colorectal cancer patients will be eligible for inclusion in this study only if all of the
following inclusion criteria apply:

1. Histologically confirmed diagnosis of invasive colorectal adenocarcinoma.

2. Clinical or radiographic evidence of metastatic disease.

3. Evidence of disease progression on the current or following the most recent therapy,
as defined by one of the following:

- New soft tissue/visceral/lymph node/bone metastatic lesion

- Growth of existing soft tissue/visceral/lymph node/bone metastases as determined
by the investigator

- Clinical progression of disease with cutaneous lesions, palpable lesions, pleural
effusions, or ascites in absence of radiographic progression

4. Enrollment prior to the initiation of a new systemic therapy.

5. Age > 18 years.

6. Ability to understand and the willingness to sign a written informed consent document.

Pancreatic cancer patients will be eligible for inclusion in this study only if all of the
following inclusion criteria apply:

1. Histologically confirmed diagnosis of invasive pancreatic adenocarcinoma.

2. Clinical or radiographic evidence of metastatic disease.

3. Enrollment prior to the initiation of a new systemic therapy.

4. Age > 18 years.

5. Ability to understand and the willingness to sign a written informed consent document.

Advanced, MET amplified, solid tumor patients will be eligible for inclusion in this study
only if all of the following inclusion criteria apply:

1. Histologically confirmed diagnosis of cancer (any kind)

2. MET gene amplification by FISH, CISH, rtPCR, or other assay as determined by the
investigator.

3. Clinical or radiographic evidence of metastatic disease.

4. Age > 18 years.

5. Ability to understand and the willingness to sign a written informed consent document.

Non-Small Cell Lung Cancer (NSCLC) patients will be eligible for inclusion in this study
only if all of the following inclusion criteria apply:

1. Histologically confirmed diagnosis of invasive non-small cell carcinoma of the lung
(includes adenocarcinoma, squamous cell carcinoma, large cell carcinoma,
adenosquamous, and carcinomas with pleomorphic, sarcomatoid, or sarcomatous elements;
does not include carcinoid tumor or neuroendocrine carcinoma).

2. Metastatic disease with either bone or visceral metastatic lesions, or clinically
symptomatic with metastatic disease.

3. Progression of disease on or following the most recent treatment as evidenced by one
of the following:

- A new soft tissue/visceral/lymph node/bone metastatic lesion

- Growth of existing soft tissue/visceral/lymph node/bone metastases as determined
by the investigator.

- Clinical progression of disease with cutaneous lesions or palpable lesions in
absence of radiographic progression

4. Progression of disease either on or following treatment with an EGFR inhibitor (such
as erlotinib, gefitinib, or other EGFR-targeted therapy)

5. Enrollment prior to the initiation of a new systemic therapy.

6. Age > 18 years.

7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria
apply:

1. History of intercurrent or past medical or psychiatric illness that would make
participation in a blood drawing protocol difficult or not feasible at the discretion
of the principal investigator or co-investigator(s).

2. Treatment with an anthracycline (including mitoxantrone, doxorubicin, epirubicin, and
daunorubicin) within 1 week of CTC collection (applicable in prostate and gastric
cancer patients), as anthracyclines cause auto-fluorescence of cells.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Andrew J Armstrong, MD

Role: Principal Investigator

Affiliation: Duke University

Overall Contact

Name: Tian Zhang, MD

Phone: (919) 970-3423

Email: tian.zhang2@duke.edu

Location

Facility Status Contact
Duke University Medical Center
Durham, North Carolina 27710
United States
Recruiting Tian Zhang, MD
919-970-3423
tian.zhang2@duke.edu