Colorectal CancerPhase 1/2NCT00003344
Radiation Therapy Plus Irinotecan in Treating Patients With Colon Cancer
A Phase 1/2 study testing irinotecan hydrochloride and radiation therapy in people with Colorectal Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- irinotecan hydrochloride and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to Jan 2000
- Phase
- Phase 1/2
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed unresectable, incompletely resected with gross residual disease, or locally recurrent large bowel carcinoma confined to a site within the abdomen or pelvis All disease must be encompassable within a single radiotherapy port No evidence of uncontrolled metastatic disease outside of the planned radiotherapy port
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Not specified Cardiovascular: No history of significant myocardial disease No New York Heart Association class III or IV disease No unstable angina No myocardial infarction in the past 4 months Other: No significant infection or other coexistent medical condition that would preclude protocol therapy Maintain an adequate oral nutrition intake (at least 1,200 calories estimated per day) No greater than 6 bowel movements per day prior to treatment No significant nausea or emesis on optimal antiemetic therapy Not pregnant or nursing Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior irinotecan Endocrine therapy: Not specified Radiotherapy: No prior abdominal or pelvic radiotherapy Surgery: At least 3 weeks since laparotomy or laparoscopic procedure with or without resection
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
About this study
Official title: Phase I-II Study of Weekly CPT-11 and Radiation Therapy for Unresectable or Locally Recurrent Large Bowel Cancer
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus irinotecan in treating patients with colon cancer that is recurrent or that cannot be removed surgically.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of weekly irinotecan that will result in an acceptable level of toxicity when given in combination with concurrent external beam radiation therapy. II. Determine the objective response rate of these patients at the dose level below the MTD.
OUTLINE: Patients receive irinotecan IV over 90 minutes beginning within 24 hours of radiotherapy on days 1, 8, 15, and 22. External beam radiotherapy is administered 5 days per week for 5.5-6 weeks starting on day 1 concurrent with chemotherapy. Cohorts of 3-6 patients are treated until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose level at which the incidence of dose limiting toxicity is no greater than one-third of the patients treated at that dose level. Once the MTD has been determined, additional patients receive irinotecan at the dose level below the MTD with external beam radiation therapy on the same treatment schedule as above. Patients are followed at 4 weeks after treatment, then every 3 months for 2 years, and then every 6 months for 3 additional years.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into the Phase I portion of this study. Approximately 15-25 patients will be accrued into the Phase II portion of this study.
- Conditions
- Colorectal Cancer
- Being tested
- irinotecan hydrochloride, radiation therapy
- Keywords
- stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer, recurrent colon cancer, recurrent rectal cancer
- 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.
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2004 (estimated)
- Study startAug 1998
- Primary completionJan 2000
- Study completionJan 2000
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 Medical University of South CarolinaThe 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 1/2
- Primary purpose
- Treatment
- Enrolment
- 49 participants
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Charles R. Thomas, MD, Study chair, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003344
- Sponsor's protocol ID
- CDR0000066321
- Other IDs
- MUSC-7532, HCC/MUSC-GI-01, NCI-V98-1420
- Status last verified
- May 2018
- First submitted
- 1 Nov 1999
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of Weekly CPT-11 and Radiation Therapy for Unresectable or Locally Recurrent Large Bowel Cancer
- ClinicalTrials.gov ID
- NCT00003344
- Acronym / sponsor ID
- CDR0000066321
- Conditions
- Colorectal Cancer
- Keywords
- stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer, recurrent colon cancer, recurrent rectal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Aug 1998
- Primary completion
- Jan 2000 (actual)
- Study completion
- Jan 2000 (actual)
- First posted
- 13 Sep 2004 (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: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus irinotecan in treating patients with colon cancer that is recurrent or that cannot be removed surgically.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of weekly irinotecan that will result in an acceptable level of toxicity when given in combination with concurrent external beam radiation therapy. II. Determine the objective response rate of these patients at the dose level below the MTD.
OUTLINE: Patients receive irinotecan IV over 90 minutes beginning within 24 hours of radiotherapy on days 1, 8, 15, and 22. External beam radiotherapy is administered 5 days per week for 5.5-6 weeks starting on day 1 concurrent with chemotherapy. Cohorts of 3-6 patients are treated until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose level at which the incidence of dose limiting toxicity is no greater than one-third of the patients treated at that dose level. Once the MTD has been determined, additional patients receive irinotecan at the dose level below the MTD with external beam radiation therapy on the same treatment schedule as above. Patients are followed at 4 weeks after treatment, then every 3 months for 2 years, and then every 6 months for 3 additional years.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into the Phase I portion of this study. Approximately 15-25 patients will be accrued into the Phase II portion of this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| irinotecan hydrochloride | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
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 16 May 2018.
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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.
Charles R. Thomas, MD study chair
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing irinotecan hydrochloride and radiation therapy in people with Colorectal Cancer, run by Medical University of South Carolina 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?
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 16 May 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 16 May 2018.