Neoplasm, Unknown PrimaryPhase 2NCT00360360
Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site
A Phase 2 study testing paclitaxel, carboplatin and bevacizumab in people with Neoplasm, Unknown Primary, run by SCRI Development Innovations, LLC at 9 sites in United States.
Trial summary
We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Unknown Primary
- What is being tested?
- paclitaxel, carboplatin and bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2006to Mar 2009
- 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
- Biopsy proven metastatic carcinoma with the following light microscopic histologies: adenocarcinoma, poorly differentiated carcinoma(must have immunoperoxidase stains to rule out lymphoma, neuroendocrine carcinoma),or poorly differentiated squamous carcinoma.
- ECOG performance status 0-1
- No previous treatment with any systemic therapy
- Adequate kidney, liver and bone marrow function
- Be able to understand the nature of the study and give written informed consent
Who cannot join
- The following specific syndromes:
- Neuroendocrine carcinoma
- Women with adenocarcinoma isolated to axillary lymph nodes
- Women with adenocarcinoma isolated to peritoneal involvement
- Carcinoma involving only one site with resectable tumors at that site
- Squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes
Show all 15Show fewer
- Uncontrolled brain metastases and all patients with meningeal involvement
- Women pregnant or lactating
- Clinically significant cardiovascular disease
- History of myocardial infarction or stroke within 6 months
- Clinical history of hemoptysis or hematemesis
- Patients with PEG tubes or G-tubes
- Proteinuria
- History of bleeding diathesis or coagulopathy
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Oncology Hematology Care
Cincinnati, Ohio, 45242
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Integrated Community Oncology Network
Jacksonville, Florida, 32256
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
About this study
Official title: A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site
We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. There is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the EGFR pathway are effective strategies in at least a proportion.
Read the detailed description
All eligible patients will receive:
- Bevacizumab 15mg/kg IV infusion,Day 1
- Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
- Carboplatin AUC 6.0 IV Day 1
- Erlotinib 150 mg by mouth daily
The regimen will be repeated every 21 days for a total of 4 courses. Patients will be initially evaluated for response after completing 2 courses (6 weeks) of treatment. Patients with an objective tumor response or stable disease will continue treatment for another 2 courses. Patients will be re-evaluated after 4 courses and those with objective tumor response or stable disease will stop chemotherapy with paclitaxel/carboplatin and continue treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of 12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12 weeks.
- Conditions
- Neoplasm, Unknown Primary
- Being tested
- paclitaxel, carboplatin, bevacizumab, erlotinib
- Keywords
- Neoplasm, Unknown Primary
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Also called Taxol
Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
carboplatinDrug
Also called Paraplatin
Carboplatin AUC 6.0 IV Day 1
bevacizumabDrug
Also called Avastin
Bevacizumab 15mg/kg IV infusion,Day 1
erlotinibDrug
Also called Tarceva
Erlotinib 150 mg by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab/Paclitaxel/Carboplatin/Erlotinib | Experimental | Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily Receives: Drug: paclitaxel; Drug: carboplatin; Drug: bevacizumab; Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Measured: 18 months
Secondary outcomes (1)
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionFeb 2008
- Study completionMar 2009
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 Neoplasm, Unknown PrimaryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- John D. Hainsworth, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360360
- Sponsor's protocol ID
- SCRI UNKPRI 19
- Status last verified
- Nov 2013
- First submitted
- 2 Aug 2006
- Last updated
- 4 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hainsworth JD, Spigel DR, Thompson DS, Murphy PB, Lane CM, Waterhouse DM, Naot Y, Greco FA. Paclitaxel/carboplatin plus bevacizumab/erlotinib in the first-line treatment of patients with carcinoma of unknown primary site. Oncologist. 2009 Dec;14(12):1189-97. doi: 10.1634/theoncologist.2009-0112. Epub 2009 Dec 4.
PubMed 19965914
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site
- ClinicalTrials.gov ID
- NCT00360360
- Acronym / sponsor ID
- SCRI UNKPRI 19
- Conditions
- Neoplasm, Unknown Primary
- Keywords
- Neoplasm, Unknown Primary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Aug 2006 (estimated)
- Results
- Posted 21 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. There is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the EGFR pathway are effective strategies in at least a proportion.
Detailed description
All eligible patients will receive:
- Bevacizumab 15mg/kg IV infusion,Day 1
- Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
- Carboplatin AUC 6.0 IV Day 1
- Erlotinib 150 mg by mouth daily
The regimen will be repeated every 21 days for a total of 4 courses. Patients will be initially evaluated for response after completing 2 courses (6 weeks) of treatment. Patients with an objective tumor response or stable disease will continue treatment for another 2 courses. Patients will be re-evaluated after 4 courses and those with objective tumor response or stable disease will stop chemotherapy with paclitaxel/carboplatin and continue treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of 12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab/Paclitaxel/Carboplatin/Erlotinib | Experimental | Drug: paclitaxel, Drug: carboplatin, Drug: bevacizumab, Drug: erlotinibBevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy proven metastatic carcinoma with the following light microscopic histologies: adenocarcinoma, poorly differentiated carcinoma(must have immunoperoxidase stains to rule out lymphoma, neuroendocrine carcinoma),or poorly differentiated squamous carcinoma.
- ECOG performance status 0-1
- No previous treatment with any systemic therapy
- Adequate kidney, liver and bone marrow function
- Be able to understand the nature of the study and give written informed consent
Key exclusion criteria (15 listed)
- The following specific syndromes:
- Neuroendocrine carcinoma
- Women with adenocarcinoma isolated to axillary lymph nodes
- Women with adenocarcinoma isolated to peritoneal involvement
- Carcinoma involving only one site with resectable tumors at that site
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 |
|---|---|---|
| paclitaxelAlso: TaxolPaclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 | Drug | Bevacizumab/Paclitaxel/Carboplatin/Erlotinib |
| carboplatinAlso: ParaplatinCarboplatin AUC 6.0 IV Day 1 | Drug | Bevacizumab/Paclitaxel/Carboplatin/Erlotinib |
| bevacizumabAlso: AvastinBevacizumab 15mg/kg IV infusion,Day 1 | Drug | Bevacizumab/Paclitaxel/Carboplatin/Erlotinib |
| erlotinibAlso: TarcevaErlotinib 150 mg by mouth daily | Drug | Bevacizumab/Paclitaxel/Carboplatin/Erlotinib |
Primary outcome
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time frame: 18 months
1 secondary outcome
Progression-free Survival
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19965914Hainsworth JD, Spigel DR, Thompson DS, Murphy PB, Lane CM, Waterhouse DM, Naot Y, Greco FA. Paclitaxel/carboplatin plus bevacizumab/erlotinib in the first-line treatment of patients with carcinoma of unknown primary site. Oncologist. 2009 Dec;14(12):1189-97. doi: 10.1634/theoncologist.2009-0112. Epub 2009 Dec 4.
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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, MD principal investigator
SCRI Development Innovations, LLC
9 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 Neoplasm, Unknown Primary, run by SCRI Development Innovations, LLC at 9 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 5 inclusion and 15 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 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 21 Oct 2013). 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 (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death (time frame: 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 NCT00360360, 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 4 Dec 2013.