Colorectal CancerPhase 2NCT00116506
Study of Bevacizumab, Erlotinib, FOLFOX for Patients With Untreated Metastatic Colorectal Cancer
A Phase 2 study testing erlotinib, FOLFOX and bevacizumab in people with Colorectal Cancer and Neoplasm Metastasis, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
Despite recent advances, most patients with advanced colorectal cancer continue to have a poor prognosis. 5-FU, leucovorin, oxaliplatin and bevacizumab is a standard treatment option for patients with stage IV colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Neoplasm Metastasis
- What is being tested?
- erlotinib, FOLFOX and bevacizumab
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2005to Jul 2007
- 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
- Eligible patients must have histologically or cytologically documented locally advanced or metastatic colorectal cancer
- No prior chemotherapy treatment for advanced or metastatic colorectal cancer. Patients may have received prior adjuvant chemotherapy or radiation with radiosensitizing chemotherapy. The last course of adjuvant chemotherapy must have concluded > 12 months prior to registration. Patients may not have previously received irinotecan, oxaliplatin, antiangiogenesis agent, or EGFR inhibitor therapy in either the adjuvant or metastatic setting. No concurrent use of additional investigational agents (including up to 4 weeks prior to enrollment) is allowed while participating in this study.
- Palliative radiation for metastatic disease is allowed, however at least 4 weeks must elapse from last treatment to first cycle of therapy and patient must have fully recovered from side effects of radiation therapy.
- Patients must have measurable disease
- Age > 18 years.
- ECOG Performance Score of 0-1.
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- Patients should have completed any major surgery > 4 weeks from registration. Patients must have completed any minor surgery (including CT or U/S guided biopsies) > 7 days from registration. Patients must have fully recovered from the procedure. (Insertion of a vascular access device is not considered major or minor surgery).
- Adequate bone marrow as evidenced by: *Absolute neutrophil count > 1,500/mL; *Platelet count > 100,000/mL
- Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL
- Adequate hepatic function as evidenced by: *Serum total bilirubin < 1.5 mg/dL; *Alkaline phosphatase < 3X the ULN (< 5X the ULN for patients with known hepatic metastases);
- SGOT/SGPT < 3X the ULN (< 5X the ULN for patients with known hepatic metastases)
- Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication.
Who cannot join
- Patients with an active infection or with a fever within 3 days of the first scheduled day of protocol treatment.
- Presence of central nervous system or brain metastases.
- History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or treated localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry.
- Patients with known hypersensitivity to any of the components of oxaliplatin, 5-fluorouracil (or other fluoropyrimidines), leucovorin, bevacizumab or erlotinib.
- Peripheral neuropathy > Grade 2.
- Patients who are pregnant or lactating.
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- Any other medical condition, including mental illness or substance abuse, deemed by the clinician to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- History of allogeneic transplant.
- Known HIV or Hepatitis B or C
- Inadequately controlled hypertension
- Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction within 6 months.
- History of stroke within 6 months.
- Clinically significant peripheral vascular disease.
- Evidence of bleeding diathesis or coagulopathy.
- Urine protein:creatinine ratio ≥ 1.0 at screening.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
- Serious, non-healing wound, ulcer, or bone fracture.
- Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusett General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Study of Bevacizumab (Avastin™) and Erlotinib (Tarceva™) in Combination With FOLFOX for Patients With Untreated Metastatic Colorectal Cancer
Despite recent advances, most patients with advanced colorectal cancer continue to have a poor prognosis. 5-FU, leucovorin, oxaliplatin and bevacizumab is a standard treatment option for patients with stage IV colorectal cancer. Fluorouracil (5-FU), leucovorin and oxaliplatin are considered traditional chemotherapies that try to stop tumor growth by affecting how they divide. Bevacizumab is a therapy to try to block the blood vessels that tumors need to grow. It is considered a 'targeted agent'. Erlotinib is another targeted agent, that has been shown to be effective in treating lung and other cancers. This trial is assessing the potential benefit of adding these second targeted agents to standard treatment.
Read the detailed description
- Patients receive bevacizumab, oxaliplatin, leucovorin, and 5-FU intravenously. The erlotinib is taken orally each day. One cycle of study therapy is 14 days. Cycles may be repeated unless there are intolerable side effects or the cancer worsens.
- Patients will undergo a tumor measurement evaluation following 3 cycles of study therapy, and then every 4 cycles thereafter.
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Being tested
- erlotinib, FOLFOX, bevacizumab
- Keywords
- Metastatic Colorectal Cancer, Bevacizumab, Erlotinib, FOLFOX
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinibDrug
FOLFOXDrug
bevacizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate 1 year progression-free survival
Secondary outcomes (1)
Determination of the observed response rate, median duration of response and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Genentech, Inc., Sanofi-Synthelabo
- Investigators
- Jeffrey Meyerhardt, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116506
- Sponsor's protocol ID
- 04-365
- Status last verified
- Dec 2007
- First submitted
- 29 Jun 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bevacizumab (Avastin™) and Erlotinib (Tarceva™) in Combination With FOLFOX for Patients With Untreated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00116506
- Acronym / sponsor ID
- 04-365
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Keywords
- Metastatic Colorectal Cancer, Bevacizumab, Erlotinib, FOLFOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Genentech, Inc., Sanofi-Synthelabo
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 30 Jun 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.
Despite recent advances, most patients with advanced colorectal cancer continue to have a poor prognosis. 5-FU, leucovorin, oxaliplatin and bevacizumab is a standard treatment option for patients with stage IV colorectal cancer. Fluorouracil (5-FU), leucovorin and oxaliplatin are considered traditional chemotherapies that try to stop tumor growth by affecting how they divide. Bevacizumab is a therapy to try to block the blood vessels that tumors need to grow. It is considered a 'targeted agent'. Erlotinib is another targeted agent, that has been shown to be effective in treating lung and other cancers. This trial is assessing the potential benefit of adding these second targeted agents to standard treatment.
Detailed description
- Patients receive bevacizumab, oxaliplatin, leucovorin, and 5-FU intravenously. The erlotinib is taken orally each day. One cycle of study therapy is 14 days. Cycles may be repeated unless there are intolerable side effects or the cancer worsens.
- Patients will undergo a tumor measurement evaluation following 3 cycles of study therapy, and then every 4 cycles thereafter.
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 (12 listed)
- Eligible patients must have histologically or cytologically documented locally advanced or metastatic colorectal cancer
- No prior chemotherapy treatment for advanced or metastatic colorectal cancer. Patients may have received prior adjuvant chemotherapy or radiation with radiosensitizing chemotherapy. The last course of adjuvant chemotherapy must have concluded > 12 months prior to registration. Patients may not have previously received irinotecan, oxaliplatin, antiangiogenesis agent, or EGFR inhibitor therapy in either the adjuvant or metastatic setting. No concurrent use of additional investigational agents (including up to 4 weeks prior to enrollment) is allowed while participating in this study.
- Palliative radiation for metastatic disease is allowed, however at least 4 weeks must elapse from last treatment to first cycle of therapy and patient must have fully recovered from side effects of radiation therapy.
- Patients must have measurable disease
- Age > 18 years.
Key exclusion criteria (19 listed)
- Patients with an active infection or with a fever within 3 days of the first scheduled day of protocol treatment.
- Presence of central nervous system or brain metastases.
- History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or treated localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry.
- Patients with known hypersensitivity to any of the components of oxaliplatin, 5-fluorouracil (or other fluoropyrimidines), leucovorin, bevacizumab or erlotinib.
- Peripheral neuropathy > Grade 2.
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 |
|---|---|---|
| erlotinib | Drug | – |
| FOLFOX | Drug | – |
| bevacizumab | Drug | – |
Primary outcome
Evaluate 1 year progression-free survival
1 secondary outcome
Determination of the observed response rate, median duration of response and overall survival
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 21 Dec 2007.
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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.
Jeffrey Meyerhardt, MD principal investigator
Dana-Farber Cancer Institute
3 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 erlotinib, FOLFOX and bevacizumab in people with Colorectal Cancer and Neoplasm Metastasis, run by Dana-Farber Cancer Institute at 3 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 12 inclusion and 19 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 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Evaluate 1 year progression-free survival. 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 21 Dec 2007.