Treatment Based on Molecular Profiling Diagnosis Carcinoma of Unknown Primary Site

NCT00737243 | Completed Phase 2 Results

• 1 other identifier: SCRI UNKPRI 20
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 21

Brief Summary

This is a non-randomized Phase II study. Patients determined at initial diagnosis to have a carcinoma of unknown primary site (CUP) will have their treatment selected with the use of a molecular profiling assay. The assay will be performed on paraffin-embedded tumor tissue from a biopsy specimen. Patients given specific diagnoses (e.g., lung, pancreas, colon, breast, renal cell, prostate and ovarian cancer) will receive treatment regimens of proven activity. If no specific diagnosis is made with the molecular profiling assay, empiric chemotherapy with paclitaxel, carboplatin, bevacizumab and erlotinib will be administered.

Conditions

Carcinoma

Keywords

Carcinoma of Unknown Primary Site; Molecular profiling assay; Bevacizumab; Erlotinib; Paclitaxel; Carboplatin

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Defined as the elapsed time from the start of treatment to the date of death from any cause or lost to follow-up. Participants lost to follow up were censored as of the last date known to be alive.

  every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months

Secondary Outcomes (1)

• Number of Participants With a Tissue of Origin Successfully Predicted by the Assay

  at baseline

Study Arms (2)

Paclitaxel, Carboplatin, Bevacizumab and Erlotinib

EXPERIMENTAL

Paclitaxel, Carboplatin, Bevacizumab and Erlotinib

Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab; Drug: Erlotinib

Treatment determined by physician

OTHER

Other treatment determined by physician based on molecular profiling assay

Drug: Bevacizumab; Drug: Erlotinib; Other: Treatment determined by physician

Interventions

Paclitaxel DRUG

175 mg/m2, 1-3 hour IV infusion Day 1

Paclitaxel, Carboplatin, Bevacizumab and Erlotinib

Carboplatin DRUG

AUC 6.0 IV Day 1

Paclitaxel, Carboplatin, Bevacizumab and Erlotinib

Bevacizumab DRUG

15 mg/kg IV infusion Day 1

Also known as: Avastin

Paclitaxel, Carboplatin, Bevacizumab and Erlotinib; Treatment determined by physician

Erlotinib DRUG

150 mg PO

Also known as: Tarceva

Paclitaxel, Carboplatin, Bevacizumab and Erlotinib; Treatment determined by physician

Treatment determined by physician OTHER

Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy

Treatment determined by physician

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• 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.
• An ECOG performance status 0, 1, or 2.
• No previous treatment with any systemic therapy.
• Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST).

You may not qualify if:

• 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.
• Patients with uncontrolled brain metastases and all patients with meningeal metastases.
• Patients with insufficient biopsy material available for molecular profiling assay.
• 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.
• Men and women of childbearing potential are required to use effective methods of contraception during this study and for 6 months after ending therapy.
• Patients who have received any other experimental drug within 28 days of starting treatment.
• 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.
• Patients with uncontrolled hypertension (systolic blood pressure \[BP\] 150 or diastolic BP \>100mm Hg) or uncontrolled cardiac arrhythmias.
• Prior hypertensive crisis or hypertensive encephalopathy.
• Patients with clinical history of hemoptysis (defined as bright red blood of

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Genentech, Inc.: collaborator

Study Sites (21)

Oncology Specialties (Clearview Cancer Institute)

Huntsville, Alabama, 35805, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Integrated Community Oncology Network

Jacksonville, Florida, 32256, United States

Location

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, 33805, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Wellstar Cancer Research

Marietta, Georgia, 30060, United States

Location

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, 47714, United States

Location

Baptist Hospital East

Louisville, Kentucky, 40207, United States

Location

Hematology Oncology Clinic, LLP

Baton Rouge, Louisiana, 70809, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Jackson Oncology Associates

Jackson, Mississippi, 39202, United States

Location

Nebraska Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Hematology Oncology Associates of Northern NJ

Morristown, New Jersey, 07960, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23235, United States

Location

Related Publications (1)

• Hainsworth JD, Rubin MS, Spigel DR, Boccia RV, Raby S, Quinn R, Greco FA. Molecular gene expression profiling to predict the tissue of origin and direct site-specific therapy in patients with carcinoma of unknown primary site: a prospective trial of the Sarah Cannon research institute. J Clin Oncol. 2013 Jan 10;31(2):217-23. doi: 10.1200/JCO.2012.43.3755. Epub 2012 Oct 1.

  PMID: 23032625 DERIVED

MeSH Terms

Conditions

Carcinoma

Interventions

Paclitaxel; Carboplatin; Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The focus of this study was to evaluate the ability of the 92-gene assay to successfully predict tumor tissue of origin, not to assess one particular treatment

Results Point of Contact

• Title: John D. Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• John D Hainsworth, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 17, 2016
• Results First Posted: August 17, 2016

Record last verified: 2016-07

Locations

US (21)