Colorectal CancerPhase 2NCT00123851
Tarceva, Capecitabine and Oxaliplatin for Metastatic Colorectal Cancer
A Phase 2 study testing Tarceva (OSI-774), Capecitabine and Oxaliplatin in people with Colorectal Cancer and Neoplasm Metastasis, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
This trial is designed to investigate the safety, tolerability and the effectiveness when OSI-774 (tarceva) is combined with oxaliplatin and capecitabine in treating patients with metastatic 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?
- Tarceva (OSI-774), Capecitabine and Oxaliplatin
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2003to Aug 2006
- 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
- Ability to understand and the willingness to sign a written informed consent document.
- Patients with histologic proof of adenocarcinoma of the colon or rectum (colorectal carcinoma) with evidence of metastatic disease.
- Patients must have received one (and only 1) prior chemotherapy regimen for metastatic disease. Patients who received adjuvant therapy and then 1 regimen for metastatic disease are eligible. Patients who received adjuvant therapy and recur within 12 months of completion of adjuvant therapy are also eligible.
- Patients who have received prior radiation therapy, either in the adjuvant or metastatic setting, for colorectal carcinoma.
- All of the following must apply:
- Greater than 4 weeks must have elapsed from the time of major surgery and patients must have recovered from the effects (e.g., laparotomy); *Greater than 2 weeks must have elapsed from the time of minor surgery and patients must have recovered from the operation. (Insertion of a vascular access device is not considered major or minor surgery.);
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- Greater than 4 weeks must have elapsed from the time of major radiotherapy [RT] (e.g., chest or bone palliative RT);
- Greater than 4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities;
- Greater than 4 weeks must have elapsed from the participation in any investigational drug study.
- ECOG performance status < 2 ; life expectancy > 12 weeks
- Patients must have normal organ and marrow function as defined below:
- ANC > 1500/mm3; hemoglobin > 9.0 gm/dl; platelets > 100,000/mm3; SGOT < 2.5x upper limits of normal if no evidence of liver metastases or < 5x upper limits of normal if evidence of liver metastases; total bilirubin < 1.5x upper limits of normal; Alk Phos < 2.5x upper limits of normal (or < 5x upper limits of normal if evidence of liver metastases or < 10x upper limits of normal if evidence of bone disease).
Who cannot join
- Patients with peripheral neuropathy of grade 2 or greater severity.
- Uncontrolled high blood pressure.
- Unstable angina.
- Symptomatic congestive heart failure.
- Myocardial infarction < 12 months prior to registration.
- Serious uncontrolled cardiac arrhythmia.
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- New York Heart Association classification III or IV.
- Active or uncontrolled infection.
- Medical or psychiatric conditions which, in the opinion of the investigator, make participation in an investigational trial of this nature a poor risk.
- Patients with known brain metastases or carcinomatous meningitis should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- No concurrent malignancy of any site, except for limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration and agree to use an effective method of contraception.
- Patients who are pregnant or lactating.
- Patients with prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
- Patients previously treated with oxaliplatin, OSI-774 or another epidermal growth factor inhibitor (EGFR).
- Patients lacking physical integrity of the upper gastrointestinal tract.
- Patients with other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer
This trial is designed to investigate the safety, tolerability and the effectiveness when OSI-774 (tarceva) is combined with oxaliplatin and capecitabine in treating patients with metastatic colorectal cancer.
Read the detailed description
Patients will be treated with OSI-774 (orally) daily, oxaliplatin (intravenously) every 3 weeks, and capecitabine (orally) twice daily for 14 days followed by a 7-day rest period. This will constitute a 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs.
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Being tested
- Tarceva (OSI-774), Capecitabine, Oxaliplatin
- Keywords
- Colorectal, Metastatic Colorectal Cancer, Oxaliplatin, Tarceva, Capecitabine, Xeloda
- 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.
Tarceva (OSI-774)Drug
CapecitabineDrug
OxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response rate of OSI-774 when given in combination with oxaliplatin and capecitabine in patients with previously-treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma
Secondary outcomes (2)
To assess overall survival, progression-free survival, time to progression and duration of response
To evaluate the toxicities of the combination of OSI-774, oxaliplatin and capecitabine in this population of patients with colorectal cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2005 (estimated)
- Study startMar 2003
- Primary completionAug 2006
- Study completionAug 2006
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 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
- 32 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo, OSI Pharmaceuticals, Hoffmann-La Roche, Genentech, Inc., Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Investigators
- Jeffrey A. Meyerhardt, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123851
- Sponsor's protocol ID
- 02-269
- Status last verified
- Apr 2009
- First submitted
- 25 Jul 2005
- Last updated
- 28 Apr 2009
- Results posted
- No
Publications
Meyerhardt JA, Zhu AX, Enzinger PC, Ryan DP, Clark JW, Kulke MH, Earle CC, Vincitore M, Michelini A, Sheehan S, Fuchs CS. Phase II study of capecitabine, oxaliplatin, and erlotinib in previously treated patients with metastastic colorectal cancer. J Clin Oncol. 2006 Apr 20;24(12):1892-7. doi: 10.1200/JCO.2005.05.3728.
PubMed 16622264
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00123851
- Acronym / sponsor ID
- 02-269
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Keywords
- Colorectal, Metastatic Colorectal Cancer, Oxaliplatin, Tarceva, Capecitabine, Xeloda
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo, OSI Pharmaceuticals, Hoffmann-La Roche, Genentech, Inc., Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Study start
- Mar 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 26 Jul 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 is designed to investigate the safety, tolerability and the effectiveness when OSI-774 (tarceva) is combined with oxaliplatin and capecitabine in treating patients with metastatic colorectal cancer.
Detailed description
Patients will be treated with OSI-774 (orally) daily, oxaliplatin (intravenously) every 3 weeks, and capecitabine (orally) twice daily for 14 days followed by a 7-day rest period. This will constitute a 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs.
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)
- Ability to understand and the willingness to sign a written informed consent document.
- Patients with histologic proof of adenocarcinoma of the colon or rectum (colorectal carcinoma) with evidence of metastatic disease.
- Patients must have received one (and only 1) prior chemotherapy regimen for metastatic disease. Patients who received adjuvant therapy and then 1 regimen for metastatic disease are eligible. Patients who received adjuvant therapy and recur within 12 months of completion of adjuvant therapy are also eligible.
- Patients who have received prior radiation therapy, either in the adjuvant or metastatic setting, for colorectal carcinoma.
- All of the following must apply:
Key exclusion criteria (17 listed)
- Patients with peripheral neuropathy of grade 2 or greater severity.
- Uncontrolled high blood pressure.
- Unstable angina.
- Symptomatic congestive heart failure.
- Myocardial infarction < 12 months prior to registration.
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 |
|---|---|---|
| Tarceva (OSI-774) | Drug | – |
| Capecitabine | Drug | – |
| Oxaliplatin | Drug | – |
Primary outcome
To determine the response rate of OSI-774 when given in combination with oxaliplatin and capecitabine in patients with previously-treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma
2 secondary outcomes
To assess overall survival, progression-free survival, time to progression and duration of response
To evaluate the toxicities of the combination of OSI-774, oxaliplatin and capecitabine in this population of patients with colorectal cancer
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 28 Apr 2009.
- Results publication: PubMed 16622264Meyerhardt JA, Zhu AX, Enzinger PC, Ryan DP, Clark JW, Kulke MH, Earle CC, Vincitore M, Michelini A, Sheehan S, Fuchs CS. Phase II study of capecitabine, oxaliplatin, and erlotinib in previously treated patients with metastastic colorectal cancer. J Clin Oncol. 2006 Apr 20;24(12):1892-7. doi: 10.1200/JCO.2005.05.3728.
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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 A. 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 Tarceva (OSI-774), Capecitabine and Oxaliplatin 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 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 28 Apr 2009. 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?
To determine the response rate of OSI-774 when given in combination with oxaliplatin and capecitabine in patients with previously-treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma. 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 NCT00123851, 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 28 Apr 2009.