Colorectal CancerPhase 3NCT00006103
Combination Chemotherapy in Treating Patients With Colorectal Cancer
A Phase 3 study testing fluorouracil, irinotecan hydrochloride and leucovorin calcium in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if the effectiveness of irinotecan combined with fluorouracil in treating colorectal cancer varies depending on the patient's racial background. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- fluorouracil, irinotecan hydrochloride and leucovorin calcium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Apr 2002
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic, locally advanced, or recurrent disease
- Patients must have at least 2 generations (parents and grandparents) who belong to one of the following racial groups:
- Asian or Pacific Islander (e.g., China, Japan, Korea, the Philippine Islands, or Samoa)
- Black (originating from the black racial groups of Africa)
- Hispanic (originating from Mexico, Puerto Rico, Cuba, Central or South America, or other Spanish culture)
- White (originating from the peoples of Europe, North Africa, or the Middle East)
- No patients with parents or grandparents of mixed race or race other than that of the patient
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- CTC 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 3 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior adjuvant fluorouracil allowed if relapse occurred at least 6 months after completion of fluorouracil
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No prior irinotecan
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormones except steroids for adrenal failure, hormones for nondisease related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
- No concurrent prednisone
Radiotherapy:
- At least 4 weeks since prior radiotherapy (except to bone or soft tissue involving less than 25% of bone marrow)
- No concurrent radiotherapy
Surgery:
- At least 4 weeks since prior major surgery
Other:
- No concurrent phenobarbital, valproate, or cyclosporine
- None of the following concurrently during first course of therapy:
- Macrolide antibiotics (e.g., azithromycin, erythromycin, clarithromycin, troleandomycin, dapsone)
- Azole antibiotics (e.g., fuconazole, miconazole, itraconazole, ketoconazole)
- Triazobenzodiazepines (e.g., alprazolam, midazolam, triazolam)
- Antidepressants (e.g., fluoxetine, setraline hydrochloride, fluoxamine, nefazodone hydrochloride)
- Quinolone antimicrobials (e.g., ciprofloxacin, ofloxacin)
- Imidazole antibiotics (e.g., clotrimazole)
- Anti-ulcer medications (e.g., omeprazole, lansoprazole)
- Ethinyl estradiol
- Diltiazem
- Cimetidine hydrochloride
- Cisapride
- Terfenadine
- Rifampin
- Glucocorticoids
- Antiepileptics
- Grapefruit juice
About this study
Official title: Interracial Study of CPT-11 (Irinotecan) Pharmacokinetics in 5-Fluorouracil Refractory Colorectal Cancer: A Population Pharmacokinetic/Pharmacodynamic Study of CPT-11
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if the effectiveness of irinotecan combined with fluorouracil in treating colorectal cancer varies depending on the patient's racial background.
PURPOSE: Phase III trial to study the effectiveness of irinotecan combined with fluorouracil in treating patients from different racial backgrounds who have colorectal cancer that is advanced, recurrent, metastatic or has not responded to treatment with fluorouracil.
Read the detailed description
OBJECTIVES:
- Determine the interracial differences in the pharmacokinetics of irinotecan in combination with fluorouracil in terms of SN-38 glucuronidation and biliary index, and gastrointestinal (GI) toxicity in patients with metastatic, locally advanced, or recurrent colorectal cancer.
- Determine if there is a significant relationship between UGT1A1 genotype (promoter and/or coding region mutation) and CYP3A4 promoter genotype, vs GI toxicity, bone marrow toxicity, and pharmacokinetics of irinotecan in this patient population.
OUTLINE: Patients are stratified according to race (Asian or Pacific Islander vs black vs Hispanic vs white).
Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for a total of 5 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 400 patients (100 per stratum) will be accrued for this study within 3 years.
- Conditions
- Colorectal Cancer
- Being tested
- fluorouracil, irinotecan hydrochloride, leucovorin calcium
- Keywords
- stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| irinotecan + leucovorin + fluorouracil | Experimental | Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for a total of 5 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months thereafter. Receives: Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2003 (estimated)
- Study startJul 2000
- Primary completionApr 2002
- Study completionApr 2002
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 Alliance for Clinical Trials in OncologyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian Leyland-Jones, MD, Study chair, McGill Cancer Centre at McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006103
- Sponsor's protocol ID
- CALGB-9864
- Other IDs
- U10CA031946, CLB-9864, E-C9864, CDR0000068113
- Status last verified
- Jul 2016
- First submitted
- 3 Aug 2000
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interracial Study of CPT-11 (Irinotecan) Pharmacokinetics in 5-Fluorouracil Refractory Colorectal Cancer: A Population Pharmacokinetic/Pharmacodynamic Study of CPT-11
- ClinicalTrials.gov ID
- NCT00006103
- Acronym / sponsor ID
- CALGB-9864
- Conditions
- Colorectal Cancer
- Keywords
- stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2000
- Primary completion
- Apr 2002 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 3 Sep 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if the effectiveness of irinotecan combined with fluorouracil in treating colorectal cancer varies depending on the patient's racial background.
PURPOSE: Phase III trial to study the effectiveness of irinotecan combined with fluorouracil in treating patients from different racial backgrounds who have colorectal cancer that is advanced, recurrent, metastatic or has not responded to treatment with fluorouracil.
Detailed description
OBJECTIVES:
- Determine the interracial differences in the pharmacokinetics of irinotecan in combination with fluorouracil in terms of SN-38 glucuronidation and biliary index, and gastrointestinal (GI) toxicity in patients with metastatic, locally advanced, or recurrent colorectal cancer.
- Determine if there is a significant relationship between UGT1A1 genotype (promoter and/or coding region mutation) and CYP3A4 promoter genotype, vs GI toxicity, bone marrow toxicity, and pharmacokinetics of irinotecan in this patient population.
OUTLINE: Patients are stratified according to race (Asian or Pacific Islander vs black vs Hispanic vs white).
Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for a total of 5 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 400 patients (100 per stratum) will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irinotecan + leucovorin + fluorouracil | Experimental | Drug: fluorouracil, Drug: irinotecan hydrochloride, Drug: leucovorin calciumPatients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for a total of 5 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months thereafter. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| fluorouracil | Drug | irinotecan + leucovorin + fluorouracil |
| irinotecan hydrochloride | Drug | irinotecan + leucovorin + fluorouracil |
| leucovorin calcium | Drug | irinotecan + leucovorin + fluorouracil |
Primary outcome
overall survival
Time frame: Up to 10 years
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 6 Jul 2016.
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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.
Brian Leyland-Jones, MD study chair
McGill Cancer Centre at McGill University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluorouracil, irinotecan hydrochloride and leucovorin calcium in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
overall survival (time frame: Up to 10 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 6 Jul 2016.