Colorectal CancerPhase 2NCT00323011
FOLFIRI + Bevacizumab With or Without Dalteparin in First Line Treatment of Advanced Colorectal Cancer
A Phase 2 study testing Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab in people with Colorectal Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. Blood clots are a problem in patients with cancer. Blood clots are also a problem in patients receiving cancer drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Nov 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
- Patients with histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.
- Age > 18 years (as no dosing or toxicity data are currently available on the use of 5-FU/CPT11 + bevacizumab + dalteparin in patients <18 years of age).
- SWOG performance status 0-1.
- Patients must have adequate organ and marrow function as defined below, with tests performed no more than seven days prior to the first study drug administration:leukocytes >3.0, absolute neutrophil count >1,500/ml,platelets > 100 X 109 L ,total bilirubin < upper normal institutional limits,AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal ( or < 5x the upper normal institutional limits in the case of liver metastases,alkaline phosphatase < 2.5 X institutional upper limit of normal ( or < 5x the upper normal institutional limits in the case of liver metastases or < 10x the upper normal institutional limits in the case of bone disease, Serum creatinine < 1.6 mg/dL OR Calculated creatinine clearance > 40 mL/min/1.73 m2, PT, PTT, within normal range, Urine protein/creatinine ratio < 1.0
- At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques.
- The effects of chemotherapy on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and 30 days from the date of the last study drug administration (postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
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- Ability to understand and willingness to sign a written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- Have a negative serum pregnancy test within 7 days prior to initiation of chemotherapy (female patients of childbearing potential).
- Life expectancy of at least 12 weeks.
- Fully recovered from any surgical procedure
Who cannot join
- Lactating woman unwilling to stop breast feeding for the duration of study participation and 30 days from the date of the last study drug administration
- History of allergy to any of the chemotherapeutics or antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.
- Prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to 5-fluorouracil, or known DPD deficiency.
- Serious, uncontrolled, intercurrent infection(s) or illnesses including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia.
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
- Current, recent (within 4 weeks of first infusion on this study) or planned participation in an investigational drug study.
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- Patients with documented DIC (disseminated intravascular coagulation).
- Patients with a previous history of a bleeding diathesis or significant bleeding episode such as gastrointestinal bleeding or a CNS hemorrhage.
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 12 months.
- Presence of central nervous system or brain mets.
- Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study.
- Unwillingness to participate or inability to comply with the protocol for the duration of the study.
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1.
- Blood pressure > 150/100 mmHg.
- Unstable angina.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction or stroke within 6 months.
- Clinically significant peripheral vascular disease.
- Evidence of bleeding diathesis or coagulopathy.
- History of abdominal fistula, gastrointestinal perforation or intrabdominal abscess within 28 days prior to Day 0.
- Serious, non-healing wound, ulcer or bone fracture.
- Carcinoma of any histology in close proximity to a major vessel, lung cavitation or history of hemoptysis.
- Completion of previous chemotherapy regimen < four weeks prior to the start of study treatment (within six weeks of study treatment for mitomycin C and nitrosureas), or with related toxicities unresolved prior to the start of study treatment.
- Patients who are taking anti coagulation therapy such as coumadin or low molecular weight Heparin.
- Patients who have an allergy against heparin.
- Medical, social or psychological factors which would interfere with consent and follow up.
- Known defective hemostasis, e.g. thrombocytopenia.
- Patients receiving Hormone Replacement Therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Pilot Study of the Activation of the Hemostatic Pathway by FOLFIRI + Bevacizumab With or Without Dalteparin in First Line Treatment of Advanced Colorectal Cancer
This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. Blood clots are a problem in patients with cancer. Blood clots are also a problem in patients receiving cancer drugs. Studies have shown that up to 17% of patients receiving cancer drugs experienced blood-clotting problems. One purpose of this study is to find if the drug combination of irinotecan, 5-fluorouracil (5-FU), bevacizumab and leucovorin (LV) affect blood-clotting factors. A second purpose of this study is to find out what effects the drug dalteparin has on clotting factors in the blood in patients receiving the drug combination of irinotecan, 5-FU, bevacizumab and LV. It is hoped that adding dalteparin to chemotherapy may benefit patients with colorectal cancer by preventing blood clots
- Conditions
- Colorectal Cancer
- Being tested
- Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: 5-FU/LV/CPT-11/Bevacizumab | Active comparator | 5-FU 400 mg/m2, days 1, 15, \& 29 Leucovorin Calcium 200 mg/m2, days 1, 15, \& 29 CPT-11 180 mg/m2, days 1, 15 \& 29 Bevacizumab 5mg/kg, days 1, 15, \& 29 Receives: Drug: Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab |
| Arm B: 5-FU/LV/CPT-11/Bevacizumab + Dalteparin | Experimental | 5-FU 400 mg/m2, days 1, 15, \& 29 5-FU 2400 continuous infusion days 1-2, 15-16, 29-30. Leucovorin Calcium 200 mg/m2, days 1, 15, \& 29 CPT-11 180 mg/m2, days 1, 15 \& 29 Bevacizumab 5mg/kg, days 1, 15, \& 29 Dalteparin 5000 IU subcutaneous starting cycle 2, days 1, 15, \& 29 Receives: Drug: Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab |
| 5-FU/LV/CPT-11/Bevacizumab+Dalteparin daily | Experimental | 5-FU 400 mg/m2, days 1, 15, \& 29 5-FU 2400 continuous infusion days 1-2, 15-16, 29-30. Leucovorin Calcium 200 mg/m2, days 1, 15, \& 29 CPT-11 180 mg/m2, days 1, 15 \& 29 Bevacizumab 5mg/kg, days 1, 15, \& 29 Dalteparin 5000 IU subcutaneous starting cycle 2, daily Receives: Drug: Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startMay 2006
- Study completionNov 2007
Why it stopped: drug not available
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 University of Southern CaliforniaThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Syma Iqbal, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323011
- Sponsor's protocol ID
- 3C-05-2
- Status last verified
- May 2014
- First submitted
- 5 May 2006
- Last updated
- 21 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of the Activation of the Hemostatic Pathway by FOLFIRI + Bevacizumab With or Without Dalteparin in First Line Treatment of Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00323011
- Acronym / sponsor ID
- 3C-05-2
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: drug not available
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 9 May 2006 (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 study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. Blood clots are a problem in patients with cancer. Blood clots are also a problem in patients receiving cancer drugs. Studies have shown that up to 17% of patients receiving cancer drugs experienced blood-clotting problems. One purpose of this study is to find if the drug combination of irinotecan, 5-fluorouracil (5-FU), bevacizumab and leucovorin (LV) affect blood-clotting factors. A second purpose of this study is to find out what effects the drug dalteparin has on clotting factors in the blood in patients receiving the drug combination of irinotecan, 5-FU, bevacizumab and LV. It is hoped that adding dalteparin to chemotherapy may benefit patients with colorectal cancer by preventing blood clots
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: 5-FU/LV/CPT-11/Bevacizumab | Active comparator | Drug: Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab5-FU 400 mg/m2, days 1, 15, \& 29 Leucovorin Calcium 200 mg/m2, days 1, 15, \& 29 CPT-11 180 mg/m2, days 1, 15 \& 29 Bevacizumab 5mg/kg, days 1, 15, \& 29 |
| Arm B: 5-FU/LV/CPT-11/Bevacizumab + Dalteparin | Experimental | Drug: Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab5-FU 400 mg/m2, days 1, 15, \& 29 5-FU 2400 continuous infusion days 1-2, 15-16, 29-30. Leucovorin Calcium 200 mg/m2, days 1, 15, \& 29 CPT-11 180 mg/m2, days 1, 15 \& 29 Bevacizumab 5mg/kg, days 1, 15, \& 29 Dalteparin 5000 IU subcutaneous starting cycle 2, days 1, 15, \& 29 |
| 5-FU/LV/CPT-11/Bevacizumab+Dalteparin daily | Experimental | Drug: Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab5-FU 400 mg/m2, days 1, 15, \& 29 5-FU 2400 continuous infusion days 1-2, 15-16, 29-30. Leucovorin Calcium 200 mg/m2, days 1, 15, \& 29 CPT-11 180 mg/m2, days 1, 15 \& 29 Bevacizumab 5mg/kg, days 1, 15, \& 29 Dalteparin 5000 IU subcutaneous starting cycle 2, daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.
- Age > 18 years (as no dosing or toxicity data are currently available on the use of 5-FU/CPT11 + bevacizumab + dalteparin in patients <18 years of age).
- SWOG performance status 0-1.
- Patients must have adequate organ and marrow function as defined below, with tests performed no more than seven days prior to the first study drug administration:leukocytes >3.0, absolute neutrophil count >1,500/ml,platelets > 100 X 109 L ,total bilirubin < upper normal institutional limits,AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal ( or < 5x the upper normal institutional limits in the case of liver metastases,alkaline phosphatase < 2.5 X institutional upper limit of normal ( or < 5x the upper normal institutional limits in the case of liver metastases or < 10x the upper normal institutional limits in the case of bone disease, Serum creatinine < 1.6 mg/dL OR Calculated creatinine clearance > 40 mL/min/1.73 m2, PT, PTT, within normal range, Urine protein/creatinine ratio < 1.0
- At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques.
Key exclusion criteria (28 listed)
- Lactating woman unwilling to stop breast feeding for the duration of study participation and 30 days from the date of the last study drug administration
- History of allergy to any of the chemotherapeutics or antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.
- Prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to 5-fluorouracil, or known DPD deficiency.
- Serious, uncontrolled, intercurrent infection(s) or illnesses including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia.
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
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 |
|---|---|---|
| Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab | Drug | 5-FU/LV/CPT-11/Bevacizumab+Dalteparin daily, Arm A: 5-FU/LV/CPT-11/Bevacizumab, Arm B: 5-FU/LV/CPT-11/Bevacizumab + Dalteparin |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: drug not available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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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.
Syma Iqbal, MD principal investigator
University of Southern California
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 Fragmin, 5-Fluorouracil, Folinic Acid, irinotecan, bevacizumab in people with Colorectal Cancer, run by University of Southern California 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 28 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: stopped early, as of the sponsor's last update on 21 May 2014. 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?
The study was stopped early (reason given: drug not available). Results are not available in the source record.
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.
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 May 2014.