CarcinomaPhase 2NCT00737243

Treatment Based on Molecular Profiling Diagnosis Carcinoma of Unknown Primary Site

A Phase 2 study testing Paclitaxel, Carboplatin and Bevacizumab in people with Carcinoma, run by SCRI Development Innovations, LLC at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma
What is being tested?: Paclitaxel, Carboplatin and Bevacizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 289 participants
Where: 21 sitesUnited States
Study dates: Aug 2008to Dec 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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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).
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.
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.
Patients must be > 4 weeks from any major operative procedure.
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.
Patients must be able to understand the nature of this study and give written informed consent.

Who cannot join

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.

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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.
Exclusion Criteria for All Patients Receiving Bevacizumab-Containing Regimens
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
½ teaspoon per episode) or hematemesis within 1 month prior to Day 1.
Patients with PEG tubes or G tubes.
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.
Core biopsy or other minor surgical procedure excluding placement of a vascular access device, within 7 days prior to Day 1.
Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1.
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.
Patients with any non-healing wound, ulcer, or long bone fracture.
Patients with any history of a bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.
Patients with a history of stroke or transient ischemic attach within 6 months prior to first bevacizumab dose.
Known hypersensitivity to any component of bevacizumab.
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.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, 70809
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Oncology Hematology Care
Cincinnati, Ohio, 45242
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Florida Cancer Specialists
Fort Myers, Florida, 33901
Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
Oncology Specialties (Clearview Cancer Institute)
Huntsville, Alabama, 35805
Jackson Oncology Associates
Jackson, Mississippi, 39202
Integrated Community Oncology Network
Jacksonville, Florida, 32256
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805
Baptist Hospital East
Louisville, Kentucky, 40207
Wellstar Cancer Research
Marietta, Georgia, 30060
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, 07960
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Nebraska Methodist Cancer Center
Omaha, Nebraska, 68114
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Virginia Cancer Institute
Richmond, Virginia, 23235
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303

Other trials in United States

About this study

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

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.

Read the detailed description

The primary objective of the study is evaluate the impact of the molecular assay prediction on the efficacy of therapy for patients with carcinoma of unknown primary site (CUP). Investigators will use tumor profiling results to direct standard, site-specific first-line therapy for patients with CUP.

Conditions: Carcinoma
Being tested: Paclitaxel, Carboplatin, Bevacizumab, Erlotinib, Treatment determined by physician
Keywords: Carcinoma of Unknown Primary Site, Molecular profiling assay, Bevacizumab, Erlotinib, Paclitaxel, Carboplatin
Medical subject headings: Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PaclitaxelDrug
175 mg/m2, 1-3 hour IV infusion Day 1
CarboplatinDrug
AUC 6.0 IV Day 1
BevacizumabDrug
Also called Avastin
15 mg/kg IV infusion Day 1
ErlotinibDrug
Also called Tarceva
150 mg PO
Treatment determined by physicianOther
Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy

Study groups in NCT00737243
Study group	Role	What they receive
Paclitaxel, Carboplatin, Bevacizumab and Erlotinib	Experimental	Paclitaxel, Carboplatin, Bevacizumab and Erlotinib Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab; Drug: Erlotinib
Treatment determined by physician	Other	Other treatment determined by physician based on molecular profiling assay Receives: Drug: Bevacizumab; Drug: Erlotinib; Other: Treatment determined by physician

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
To evaluate the utility of the assay in identifying the tissue of origin in patients with carcinoma of unknown primary site (CUP), an archived tumor specimen was assayed upon study entry. If a tissue of origin was predicted by the assay, participants received standard site-specific therapy for that tumor type. When tissue of origin was not predicted by the assay, patients received standard empiric chemotherapy for CUP and were not followed further. If the assay was not completed due to inadequate amount of tumor in the biopsy specimen, patients were not treated on the study.
Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Dec 2012

First posted18 Aug 2008 (estimated)
Study startAug 2008
Primary completionNov 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 289 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00737243
Sponsor's protocol ID: SCRI UNKPRI 20
Status last verified: Jul 2016
First submitted: 15 Aug 2008
Last updated: 17 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23032625

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Chemotherapy Treatment Based on Molecular Profiling Diagnosis for Patients With Carcinoma of Unknown Primary Site
ClinicalTrials.gov ID: NCT00737243
Acronym / sponsor ID: SCRI UNKPRI 20
Conditions: Carcinoma
Keywords: Carcinoma of Unknown Primary Site, Molecular profiling assay, Bevacizumab, Erlotinib, Paclitaxel, Carboplatin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 289 participants (actual)
Lead sponsor: SCRI Development Innovations, LLCUniversity, hospital or other
Collaborators: Genentech, Inc.
Study start: Aug 2008
Primary completion: Nov 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 18 Aug 2008 (estimated)
Results: Posted 17 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Paclitaxel, Carboplatin, Bevacizumab and Erlotinib	Experimental	Drug: Paclitaxel, Drug: Carboplatin, Drug: Bevacizumab, Drug: ErlotinibPaclitaxel, Carboplatin, Bevacizumab and Erlotinib
Treatment determined by physician	Other	Drug: Bevacizumab, Drug: Erlotinib, Other: Treatment determined by physicianOther treatment determined by physician based on molecular profiling assay

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

Patients must have carcinoma of unknown primary site after the following diagnostic procedures have been performed and are unrevealing of a primary site:
Patients must have biopsy-proven metastatic carcinoma, with any of the following light microscopic histologies:
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.

Key exclusion criteria (28 listed)

Patients with the following specific syndromes are not eligible:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Paclitaxel175 mg/m2, 1-3 hour IV infusion Day 1	Drug	Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
CarboplatinAUC 6.0 IV Day 1	Drug	Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
BevacizumabAlso: Avastin15 mg/kg IV infusion Day 1	Drug	Paclitaxel, Carboplatin, Bevacizumab and Erlotinib, Treatment determined by physician
ErlotinibAlso: Tarceva150 mg PO	Drug	Paclitaxel, Carboplatin, Bevacizumab and Erlotinib, Treatment determined by physician
Treatment determined by physicianPatients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy	Other	Treatment determined by physician

Primary outcome

Overall Survival
Time frame: every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months
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.

1 secondary outcome

Number of Participants With a Tissue of Origin Successfully Predicted by the Assay
Time frame: at baseline

Results and safety

Results posted to the registry on 17 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients With a Successful Tumor Assays Performed	289	194

Primary outcome: Overall Survival

Time frame: every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months. Median (95% Confidence Interval). Unit: months

Measure	More Treatment Responsive n = 115	Less Treatment Responsive n = 79
Value	13.43 (10.57 to 16.03)	7.62 (6.04 to 15.11)

Population analysed: Of 223 treated patients: 194 received assay-directed therapy; 29 received empiric CUP therapy. The 194 patients who received assay-directed therapy were separated into groups based on predicted responsiveness of the tumor type for further analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: every 6-8 weeks (2 cycles) up to 48 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Treated Patients	30 of 223 (13.5%)	74 of 223 (33.2%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23032625Hainsworth 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John D Hainsworth, M.D. study chair

SCRI Development Innovations, LLC

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Carboplatin and Bevacizumab in people with Carcinoma, run by SCRI Development Innovations, LLC at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00737243, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.