Gastroesophageal CancerPhase 2NCT00673673
FOLFOX With Bevacizumab in Metastatic or Unresectable Gastroesophageal and Gastric Cancer
A Phase 2 study testing FOLFOX and bevacizumab in people with Gastroesophageal Cancer and Gastric Cancer, run by Yale University at 2 sites in United States.
Trial summary
This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or unresectable gastroesophageal and gastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Cancer, Gastric Cancer
- What is being tested?
- FOLFOX and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Jul 2014
- 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
- Histologically or cytologically documented recurrent, metastatic or unresectable gastroesophageal (Siewert type I, II, III) or gastric adenocarcinoma with measurable or assessable non-measurable disease (RECIST criteria).
- If recurrent or metastatic disease is not histologically confirmed, then documentation by a second radiographic procedure (i.e., PET scan or MRI in addition to CT scan) is required. If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation is required
- 12 months since completion of any prior neoadjuvant or adjuvant therapy (chemotherapy or radiotherapy) for potentially resectable gastroesophageal or gastric adenocarcinoma.
- >4 weeks since major surgery.
- ECOG Performance Status: 0-1
- Life expectancy >12 weeks
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- Laboratory parameters as follows: absolute neutrophil count ≥1,500/uL, platelet count ≥100,000/uL, hemoglobin ≥9 g,/dL, creatinine <1.5 X ULN or estimated GFR >30 ml's/min, urinalysis <2+ protein, baseline proteinuria <1000 mg/d or urine protein/creatinine ratio <1, bilirubin <2 X ULN, PT (INR) <1.5 if patient not on anticoagulation, negative pregnancy test in women of childbearing age
- Hypertension must be well controlled (<160/90)
- Paraffin block or slides must be available
- Patients on full-dose anticoagulants must be on a stable dose of warfarin and have an in-range INR or be on a stable dose of low molecular weight heparin.
Who cannot join
- prior treatment for recurrent, metastatic, or unresectable gastroesophageal or gastric adenocarcinoma
- other concurrent anticancer therapy
- other malignancy within past three years except basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer known central nervous system metastases or carcinomatous meningitis.
- interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
- > grade 2 sensory peripheral neuropathy.
- uncontrolled seizure disorder, active neurological disease, or known CNS disease.
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- significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment.
- history of hypertensive crisis or hypertensive encephalopathy
- abdominal fistula, gastrointestinal bleeding, or intra-abdominal abscess within the 6 months prior to study enrollment.
- core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
- 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.
- recent arterial thrombotic events including stroke or TIA within 6 months prior to study enrollment.
- serious or non-healing wound, ulcer or bone fracture.
- active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical Oncology & Hematology PC
Hamden, Connecticut
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: Phase II Study of FOLFOX With Bevacizumab (Avastin(TM)) in Metastatic or Unresectable Gastroesophageal and Gastric Cancer
This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or unresectable gastroesophageal and gastric adenocarcinoma. Our primary objective is to determine the time to progression in patients treated with FOLFOX in combination with bevacizumab.
- Conditions
- Gastroesophageal Cancer, Gastric Cancer
- Being tested
- FOLFOX, bevacizumab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXDrug
Also called Eloxatin, Fluorouracil
Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
bevacizumabDrug
Also called Avastin
bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FOLFOX in combination with bevacizumab Receives: Drug: FOLFOX; Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: Upon completion of study, up to 3 years
Secondary outcomes (2)
Overall Tumor Response Rate by RECIST Criteria
Per response evaulation criteria in solid tumors criteria (RECIST) for target lesions assessed by FDG-PET Scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Measured: Upon completion of study
Overall Survival
Measured: Upon completion of study, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2013
- Study completionJul 2014
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 Gastroesophageal CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Jill Lacy, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673673
- Sponsor's protocol ID
- 0710003118
- Status last verified
- Jan 2015
- First submitted
- 5 May 2008
- Last updated
- 4 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of FOLFOX With Bevacizumab (Avastin(TM)) in Metastatic or Unresectable Gastroesophageal and Gastric Cancer
- ClinicalTrials.gov ID
- NCT00673673
- Acronym / sponsor ID
- 0710003118
- Conditions
- Gastroesophageal Cancer, Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- May 2008
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 14 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or unresectable gastroesophageal and gastric adenocarcinoma. Our primary objective is to determine the time to progression in patients treated with FOLFOX in combination with bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FOLFOX, Drug: bevacizumabFOLFOX in combination with 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)
- Histologically or cytologically documented recurrent, metastatic or unresectable gastroesophageal (Siewert type I, II, III) or gastric adenocarcinoma with measurable or assessable non-measurable disease (RECIST criteria).
- If recurrent or metastatic disease is not histologically confirmed, then documentation by a second radiographic procedure (i.e., PET scan or MRI in addition to CT scan) is required. If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation is required
- 12 months since completion of any prior neoadjuvant or adjuvant therapy (chemotherapy or radiotherapy) for potentially resectable gastroesophageal or gastric adenocarcinoma.
- >4 weeks since major surgery.
- ECOG Performance Status: 0-1
Key exclusion criteria (14 listed)
- prior treatment for recurrent, metastatic, or unresectable gastroesophageal or gastric adenocarcinoma
- other concurrent anticancer therapy
- other malignancy within past three years except basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer known central nervous system metastases or carcinomatous meningitis.
- interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
- > grade 2 sensory peripheral neuropathy.
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 |
|---|---|---|
| FOLFOXAlso: Eloxatin, FluorouracilOxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours | Drug | 1 |
| bevacizumabAlso: Avastinbevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy | Drug | 1 |
Primary outcome
Progression Free Survival
Time frame: Upon completion of study, up to 3 years
2 secondary outcomes
Overall Tumor Response Rate by RECIST Criteria
Time frame: Upon completion of study
Overall Survival
Time frame: Upon completion of study, up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- 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.
Jill Lacy, M.D. principal investigator
Yale University
2 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 FOLFOX and bevacizumab in people with Gastroesophageal Cancer and Gastric Cancer, run by Yale University at 2 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 10 inclusion and 14 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 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 14 Jul 2014). 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?
Progression Free Survival (time frame: Upon completion of study, up to 3 years). 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 4 Feb 2015.