Neoplasms, Unknown PrimaryPhase 2NCT00193622
Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site
A Phase 2 study testing Bevacizumab and Erlotinib in people with Neoplasms, Unknown Primary, run by SCRI Development Innovations, LLC.
Trial summary
This trial will investigate the combination of bevacizumab, and erlotinib in patients with adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Unknown Primary
- What is being tested?
- Bevacizumab and Erlotinib
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- To be included in this study, you must meet the following criteria:
- Carcinoma of unknown primary site confirmed by biopsy
- Measurable disease
- ECOG performance status must be 0-1
- Adequate bone marrow, liver and kidney
- Understand the nature of this study and give written informed consent.
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Age< 18 years
- May not have received EGFR inhibitors
- History of acute myocardial infarction within 6 months
- Clinically significant cardiovascular disease
- Moderate to severe peripheral vascular disease.
Show all 17Show fewer
- History of stroke within 6 months
- History of abdominal fistula, perforation, or abscess within 6 months
- Active concurrent infections
- Serious underlying medical conditions
- Active brain metastases
- Women who are pregnant or lactating.
- PEG or G-tube
- Proteinuria
- Any nonhealing wound, ulcer, or bone fracture.
- Any clinical evidence or history of bleeding, clotting 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.
About this study
Official title: A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site
This trial will investigate the combination of bevacizumab, and erlotinib in patients with adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. This trial will be one of the first clinical trials to evaluate a combination of targeted agents in the treatment of a solid tumor.
Read the detailed description
Upon determination of eligibility, patients will be receive:
- Bevacizumab + Erlotinib
- Conditions
- Neoplasms, Unknown Primary
- Being tested
- Bevacizumab, Erlotinib
- 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.
BevacizumabDrug
ErlotinibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Secondary outcomes (4)
Time to progression
Overall survival
Overall tolerability
Overall toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionSep 2005
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- John D. Hainsworth, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193622
- Sponsor's protocol ID
- SCRI UNKPRI 15
- Other IDs
- AVF 2968s
- Status last verified
- Sep 2010
- First submitted
- 12 Sep 2005
- Last updated
- 17 Sep 2010
- Results posted
- No
Publications
Hainsworth JD, Spigel DR, Farley C, Thompson DS, Shipley DL, Greco FA; Minnie Pearl Cancer Research Network. Phase II trial of bevacizumab and erlotinib in carcinomas of unknown primary site: the Minnie Pearl Cancer Research Network. J Clin Oncol. 2007 May 1;25(13):1747-52. doi: 10.1200/JCO.2006.09.3047.
PubMed 17470864
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site
- ClinicalTrials.gov ID
- NCT00193622
- Acronym / sponsor ID
- SCRI UNKPRI 15
- Conditions
- Neoplasms, Unknown Primary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will investigate the combination of bevacizumab, and erlotinib in patients with adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. This trial will be one of the first clinical trials to evaluate a combination of targeted agents in the treatment of a solid tumor.
Detailed description
Upon determination of eligibility, patients will be receive:
- Bevacizumab + Erlotinib
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Carcinoma of unknown primary site confirmed by biopsy
- Measurable disease
- ECOG performance status must be 0-1
- Adequate bone marrow, liver and kidney
- Understand the nature of this study and give written informed consent.
Key exclusion criteria (17 listed)
- Age< 18 years
- May not have received EGFR inhibitors
- History of acute myocardial infarction within 6 months
- Clinically significant cardiovascular disease
- Moderate to severe peripheral vascular disease.
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 |
|---|---|---|
| Bevacizumab | Drug | – |
| Erlotinib | Drug | – |
Primary outcome
Overall response rate
4 secondary outcomes
Time to progression
Overall survival
Overall tolerability
Overall toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
- Results publication: PubMed 17470864Hainsworth JD, Spigel DR, Farley C, Thompson DS, Shipley DL, Greco FA; Minnie Pearl Cancer Research Network. Phase II trial of bevacizumab and erlotinib in carcinomas of unknown primary site: the Minnie Pearl Cancer Research Network. J Clin Oncol. 2007 May 1;25(13):1747-52. doi: 10.1200/JCO.2006.09.3047.
Related trials for Neoplasms, Unknown Primary
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Smartphone-Based Self-Registration of Health Data in Patients With Severe Unspecific Symptoms or Cancer of Unknown Primary
Advanced Unspecific Symptom, Cancer of Unknown Primary Site
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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Erlotinib in people with Neoplasms, Unknown Primary, run by SCRI Development Innovations, LLC.
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 6 inclusion and 17 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 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 response rate. 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 NCT00193622, 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 Sep 2010.