CancerPhase 2NCT00222729
Study of Pemetrexed and Bevacizumab in Patients With Head and Neck Cancer
A Phase 2 study testing Pemetrexed and Bevacizumab in people with Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to determine if the combination of two new drugs pemetrexed (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Pemetrexed and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Oct 2013
- 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
- Metastatic or locally recurrent squamous cell carcinoma of the head and neck. Patients with local recurrence will be considered incurable by means of locoregional therapy, as judged by the investigator.
- Cytologically or histologically confirmed squamous cell carcinoma. Nasopharyngeal carcinoma of histologic subtype WHO II and III will be excluded.
- Unidimensional measurable disease (RECIST criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
- ECOG performance status 0-1.
- Full recovered from the effects of any prior surgery, or radiation therapy. A minimum time period of 3 weeks will elapse between the completion of extensive radiation therapy for recurrent/metastatic disease and enrollment in the study
- Laboratory values:
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- ANC ³ 1500/mm³. Platelets ³ 100,000/mm³. Total Bilirubin within normal institutional limits.
- Transaminases (AST and ALT) < 3 x ULN. Creatinine clearance 45 ml/min or higher calculated using the Cockcroft-Gault formula.
- Urine protein to creatinine (UPC) ratio of ≤ 1.0 on spot urine urinalysis.
- Age > 18 years and capacity to give informed consent.
Who cannot join
- Prior chemotherapy or biologic therapy for recurrent/metastatic head and neck cancer.
- Prior pemetrexed, bevacizumab, or other antiangiogenesis agents at any time.
- Presence of tumors that invaded major vessels.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to study enrollment.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration. Serious non-healing wound, ulcer, or bone fracture.
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- History of brain metastasis or seizures.
- Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 5-year disease-free interval.
- Pre-existing peripheral neuropathy > grade 2.
- Myocardial infarction or stroke in the last 6 months. Unstable angina; Heart Association (NYHA) Grade II or greater congestive heart failure; Clinically significant peripheral vascular disease; CNS cerebrovascular ischemia within the last 6 months; active serious infection; other coexisting medical condition that would preclude full compliance with the study
- Bleeding diathesis or coagulopathy.
- Therapeutic anticoagulation (prophylactic use of warfarin 1 mg per day is allowed) or INR greater than 1.5 at registration
- History of gross hemoptysis (defined as bright red blood of a ½ teaspoon or more).
- Uncontrolled hypertension (>150/100)
- Pregnant or lactating.
- Use of NSAIDs within 5 days of protocol therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15216
About this study
Official title: Phase II Trial of Pemetrexed and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
The purpose of this study is to determine if the combination of two new drugs pemetrexed (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Currently pemetrexed is approved by the Food and Drug Administration (FDA) for another type of cancer, mesothelioma, but it is not approved for head and neck cancer.
Read the detailed description
Main objectives of this study are to 1) evaluate the time to progression (primary endpoint) with the combination of pemetrexed and bevacizumab in recurrent or metastatic head and neck cancer; 2) evaluate the objective response rate, duration of response, overall survival, and toxicities associated with the above therapy and 3) collect tumor tissue from previous diagnostic procedures and blood specimens prospectively, before and after therapy, for future correlative studies.
- Conditions
- Cancer
- Being tested
- Pemetrexed, Bevacizumab
- Keywords
- head, neck
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called (N-[4-[2-(2-amino-3,4-dihydron-4-oxo-7H-pyrolo[2,3-d]pyrinidin-5-yl)ethyl]benzoyl]-L-glutamic acid), Alimta, pemetrexed disodium, LY231514, MTA
500 mg/m2 day 1 q 21 days
BevacizumabDrug
Also called NSC 704865, RhuMAb VEGF, Bevacizumab, Avastin
15 mg/kg IV q 21 days following pemetrexed
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed & Bevacizumab | Experimental | Not described Receives: Drug: Pemetrexed; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-progression (TTP)
TTP was calculated from treatment initiation to disease progression or last follow-up.
Measured: Up to 36 months
Secondary outcomes (3)
Objective Response Rate (ORR)
Measured: Up to 36 months
Disease Control Rate (DCR)
Measured: Up to 36 months
Overall Survival (OS)
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionOct 2013
- Study completionOct 2013
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.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Julie Bauman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222729
- Sponsor's protocol ID
- 05-002
- Other IDs
- 12,158
- Status last verified
- Jan 2016
- First submitted
- 16 Sep 2005
- Last updated
- 15 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Pemetrexed and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00222729
- Acronym / sponsor ID
- 05-002
- Conditions
- Cancer
- Keywords
- head, neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Genentech, Inc.
- Study start
- Nov 2005
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 15 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the combination of two new drugs pemetrexed (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Currently pemetrexed is approved by the Food and Drug Administration (FDA) for another type of cancer, mesothelioma, but it is not approved for head and neck cancer.
Detailed description
Main objectives of this study are to 1) evaluate the time to progression (primary endpoint) with the combination of pemetrexed and bevacizumab in recurrent or metastatic head and neck cancer; 2) evaluate the objective response rate, duration of response, overall survival, and toxicities associated with the above therapy and 3) collect tumor tissue from previous diagnostic procedures and blood specimens prospectively, before and after therapy, for future correlative studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed & Bevacizumab | Experimental | Drug: Pemetrexed, Drug: Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Metastatic or locally recurrent squamous cell carcinoma of the head and neck. Patients with local recurrence will be considered incurable by means of locoregional therapy, as judged by the investigator.
- Cytologically or histologically confirmed squamous cell carcinoma. Nasopharyngeal carcinoma of histologic subtype WHO II and III will be excluded.
- Unidimensional measurable disease (RECIST criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
- ECOG performance status 0-1.
- Full recovered from the effects of any prior surgery, or radiation therapy. A minimum time period of 3 weeks will elapse between the completion of extensive radiation therapy for recurrent/metastatic disease and enrollment in the study
Key exclusion criteria (16 listed)
- Prior chemotherapy or biologic therapy for recurrent/metastatic head and neck cancer.
- Prior pemetrexed, bevacizumab, or other antiangiogenesis agents at any time.
- Presence of tumors that invaded major vessels.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to study enrollment.
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 |
|---|---|---|
| PemetrexedAlso: (N-[4-[2-(2-amino-3,4-dihydron-4-oxo-7H-pyrolo[2,3-d]pyrinidin-5-yl)ethyl]benzoyl]-L-glutamic acid), Alimta, pemetrexed disodium, LY231514, MTA500 mg/m2 day 1 q 21 days | Drug | Pemetrexed & Bevacizumab |
| BevacizumabAlso: NSC 704865, RhuMAb VEGF, Bevacizumab, Avastin15 mg/kg IV q 21 days following pemetrexed | Drug | Pemetrexed & Bevacizumab |
Primary outcome
Time-to-progression (TTP)
Time frame: Up to 36 months
TTP was calculated from treatment initiation to disease progression or last follow-up.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 36 months
Disease Control Rate (DCR)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Julie Bauman, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed and Bevacizumab in people with Cancer, run by University of Pittsburgh at 1 site 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 10 inclusion and 16 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 15 Feb 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?
Time-to-progression (TTP) (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.