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A Phase II Study of Chemotherapy Treatment Based on Molecular Profiling Diagnosis for Patients With Carcinoma of Unknown Primary Site

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Study of Chemotherapy Treatment Based on Molecular Profiling Diagnosis for Patients With Carcinoma of Unknown Primary Site

Patients in all subgroups will be evaluated for response to treatment after completing 2
cycles. Standard, disease specific, restaging methods will be employed. Patients with
objective response or stable disease will continue treatment, with subsequent re-evaluations
after every 2 cycles of therapy.

Inclusion Criteria:

1. Patients must have carcinoma of unknown primary site after the following diagnostic
procedures have been performed and are unrevealing of a primary site:

- Complete medical history and physical examination,

- Complete blood counts, chemistry profile,

- CT scans of the chest and abdomen,

- Directed evaluation of any symptomatic areas,

- PET scan (recommended).

2. Patients must have biopsy-proven metastatic carcinoma, with any of the following
light microscopic histologies:

- Adenocarcinoma,

- Poorly differentiated adenocarcinoma,

- Poorly differentiated carcinoma (all patients with poorly differentiated
carcinoma must have immunoperoxidase stains to rule out other treatable
malignancies [e.g., lymphoma, neuroendocrine carcinoma]),

- Poorly differentiated squamous carcinoma.

3. Patients must have biopsy material available from a surgical biopsy, a core needle
biopsy, or a fine needle aspiration biopsy to provide an adequate specimen (must be
40% tumor) for the molecular profiling assay.

4. An ECOG performance status 0, 1, or 2.

5. No previous treatment with any systemic therapy.

6. Measurable or evaluable disease according to the Response Evaluation Criteria in
Solid Tumors (RECIST).

7. Laboratory values as follows:

- WBC 4000/micro L,

- Platelets 100,000/micro L,

- Serum bilirubin <1.5 times the institutional upper limits of normal (ULN),

- Serum creatinine < 2.0 mg/dL.

8. Patients with brain metastases are eligible only if all lesions have been controlled
by surgical resection or radiation therapy, the patient is not steroid-dependent, and
the patient meets all other eligibility criteria.

9. Patients must be > 4 weeks from any major operative procedure.

10. To be eligible for the TREATMENT portion of the study, patients must have one of the
five following diagnoses: colorectal, pancreas, NSCLC, ovary, renal cancer.

11. Patients must be able to understand the nature of this study and give written
informed consent.

Exclusion Criteria:

1. Patients with the following specific syndromes are not eligible:

- Patients with neuroendocrine carcinoma,

- Women with adenocarcinoma isolated to axillary lymph nodes,

- Women with adenocarcinoma isolated to peritoneal involvement,

- Patients with carcinoma involving only 1 site, with resectable tumor at that
site, or

- Patients with squamous carcinoma limited to cervical, supraclavicular, or
inguinal lymph nodes.

2. Patients with uncontrolled brain metastases and all patients with meningeal

3. Patients with insufficient biopsy material available for molecular profiling assay.

4. Women who are pregnant or lactating. All females of child-bearing potential must have
a negative serum or urine pregnancy tests within 7 days prior to study treatment.

5. Men and women of childbearing potential are required to use effective methods of
contraception during this study and for 6 months after ending therapy.

6. Patients who have received any other experimental drug within 28 days of starting

Exclusion Criteria for All Patients Receiving Bevacizumab-Containing Regimens

1. Patients with history of acute myocardial infarction within 6 months, other
clinically significant cardiovascular disease (e.g., unstable angina, New York Heart
Association [NYHA] grade 2 congestive heart failure [CHF], serious cardiac
arrhythmias requiring medication) or > grade 2 vascular disease.

2. Patients with uncontrolled hypertension (systolic blood pressure [BP] 150 or
diastolic BP >100mm Hg) or uncontrolled cardiac arrhythmias.

3. Prior hypertensive crisis or hypertensive encephalopathy.

4. Patients with clinical history of hemoptysis (defined as bright red blood of

½ teaspoon per episode) or hematemesis within 1 month prior to Day 1.

5. Patients with PEG tubes or G tubes.

6. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1 or anticipation of need for major surgical procedure during the course
of the study.

7. Core biopsy or other minor surgical procedure excluding placement of a vascular
access device, within 7 days prior to Day 1.

8. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months prior to Day 1.

9. Patients with proteinuria (1000 mg/24 hours) at screening will be excluded. A 24-hour
urine collection is not required in all patients (e.g., patients whose treatment
plans exclude bevacizumab); however, all patients receiving bevacizumab with 1+
proteinuria on dipstick urinalysis at study entry must have a subsequent 24-hour
urine collection.

10. Patients with any non-healing wound, ulcer, or long bone fracture.

11. Patients with any history of a bleeding diathesis or coagulopathy (in the absence of
therapeutic anticoagulation).

12. Patients with a history of abdominal fistula, gastrointestinal perforation, or
intra-abdominal abscess within 6 months prior to beginning bevacizumab.

13. Patients with a history of stroke or transient ischemic attach within 6 months prior
to first bevacizumab dose.

14. Known hypersensitivity to any component of bevacizumab.

15. Patients with history of any other disease, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of a novel regimen, or that might affect the results of this
study or render the subject at high risk for treatment complications.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the utility of the 92-gene RT-PCR assay in identifying the tissue of origin in patients with carcinoma of unknown primary site.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

John D Hainsworth, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

August 2014

Related Keywords:

  • Carcinoma
  • Carcinoma of Unknown Primary Site
  • Molecular profiling assay
  • Bevacizumab
  • Erlotinib
  • Paclitaxel
  • Carboplatin
  • Carcinoma
  • Neoplasms, Unknown Primary



Florida Hospital Cancer Institute Orlando, Florida  32804
Florida Cancer Specialists Fort Myers, Florida  33901
Northeast Georgia Medical Center Gainesville, Georgia  30501
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Virginia Cancer Institute Richmond, Virginia  23230
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Jackson Oncology Associates Jackson, Mississippi  39202
Wellstar Cancer Research Marietta, Georgia  30060
Oncology Hematology Care Cincinnati, Ohio  45242
Watson Clinic Center for Cancer Care and Research Lakeland, Florida  33805
Oncology Hematology Associates of SW Indiana Evansville, Indiana  47714
Baptist Hospital East Louisville, Kentucky  40207
Hematology Oncology Clinic, LLP Baton Rouge, Louisiana  70809
Hematology Oncology Associates of Northern NJ Morristown, New Jersey  07960
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404
Nebraska Methodist Cancer Center Omaha, Nebraska  68114
Oncology Specialties (Clearview Cancer Institute) Huntsville, Alabama  35805
Center for Cancer and Blood Disorders Ft. Worth, Texas  76104