Carcinoma of Unknown PrimaryPhase 2NCT00004005
Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin
A Phase 2 study testing fluorouracil, irinotecan hydrochloride and leucovorin calcium in people with Carcinoma of Unknown Primary and Colorectal Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study
- Who is it for?
- Ages Up to 24 years
- Conditions the study is for
- Carcinoma of Unknown Primary, Colorectal Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- fluorouracil, irinotecan hydrochloride and leucovorin calcium
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1998to Oct 2005
- 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 Up to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- One of the following diagnoses:
- Histologically proven previously untreated stage III or stage IV colorectal carcinoma
- Other carcinomas refractory to standard treatment
- Metastatic adenocarcinoma of unknown primary site
PATIENT CHARACTERISTICS:
Age:
- Under 25
Performance status:
- ECOG 0-2
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Hemoglobin at least 10.0 g/dL
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Albumin greater than 3.0 g/dL
- Bilirubin less than 1.5 mg/dL
- SGOT or SGPT less than 2 times normal
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 80 mL/min
- Urinalysis normal
Other:
- Blood glucose normal
- Electrolytes normal
- Prior curatively treated childhood cancer allowed
- Weight greater than 10th percentile for height
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Irinotecan and 5-Fluorouracil/Leucovorin for Patients With Colorectal Carcinoma and Other Refractory Tumors
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III or stage IV colorectal carcinoma (cancer), other refractory carcinoma (cancer), or metastatic adenocarcinoma (cancer) of unknown primary origin.
Read the detailed description
OBJECTIVES:
- Determine the response rate in patients with stage IV colorectal carcinoma or other carcinomas treated with irinotecan followed by fluorouracil and leucovorin calcium.
- Determine the disease-free survival of patients with stage III colorectal carcinoma, other refractory carcinomas, or metastatic adenocarcinomas of unknown primary site treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients with stage III colorectal carcinoma (post surgical resection) receive irinotecan IV over 1 hour on days 1-5 and days 8-12. Treatment repeats every 3 weeks for 2 courses. Beginning on week 7, patients receive pelvic irradiation, leucovorin calcium IV over 4 hours, and fluorouracil IV over 5-15 minutes beginning 1 hour into leucovorin calcium infusion on days 1-5. Treatment repeats every 3 weeks for a total of 2 courses. Patients with no evidence of disease may repeat the above 12-week block of chemotherapy without pelvic irradiation up to 4 times over 1 year.
Patients with stage IV colorectal carcinoma, other refractory carcinomas, or metastatic adenocarcinomas of unknown primary site receive the above 12-week block of chemotherapy (irinotecan, fluorouracil, and leucovorin calcium) with pelvic irradiation (if indicated). Pelvic irradiation patients with an unresected primary tumor undergo exploratory surgery 4-5 weeks after completion of radiotherapy, even in the absence of visible tumor regression. Radical resection is attempted to effect local control and control of long term symptoms related to the primary tumor. Patients with complete response (CR) or partial response (PR) after both chemotherapy and surgery repeat the above 12-week block of chemotherapy 3 times over 1 year in the absence of disease progression or unacceptable toxicity. Patients with CR or PR after chemotherapy but no response after surgery receive irinotecan IV over 1 hour on days 1-5 and days 8-12 every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable disease (SD) or progressive disease after 2 courses of irinotecan and SD, CR, or PR after surgery receive leucovorin calcium and fluorouracil as above every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 years.
- Conditions
- Carcinoma of Unknown Primary, Colorectal Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- fluorouracil, irinotecan hydrochloride, leucovorin calcium, conventional surgery, radiation therapy
- Keywords
- stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, unspecified childhood solid tumor, protocol specific, unspecified adult solid tumor, protocol specific, adenocarcinoma of unknown primary, newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary
- Medical subject headings
- Neoplasms, Unknown Primary, 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.
fluorouracilDrug
conventional surgeryProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Toxicity
Disease-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1998
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of Unknown PrimaryStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Wayne Lee Furman, MD, Study chair, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004005
- Sponsor's protocol ID
- CDR0000067216
- Other IDs
- P30CA021765, SJCRH-CACO5, NCI-G99-1554
- Status last verified
- Oct 2011
- First submitted
- 1 Nov 1999
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan and 5-Fluorouracil/Leucovorin for Patients With Colorectal Carcinoma and Other Refractory Tumors
- ClinicalTrials.gov ID
- NCT00004005
- Acronym / sponsor ID
- CDR0000067216
- Conditions
- Carcinoma of Unknown Primary, Colorectal Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, unspecified childhood solid tumor, protocol specific, unspecified adult solid tumor, protocol specific, adenocarcinoma of unknown primary, newly diagnosed carcinoma of unknown primary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1998
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 27 Jan 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, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III or stage IV colorectal carcinoma (cancer), other refractory carcinoma (cancer), or metastatic adenocarcinoma (cancer) of unknown primary origin.
Detailed description
OBJECTIVES:
- Determine the response rate in patients with stage IV colorectal carcinoma or other carcinomas treated with irinotecan followed by fluorouracil and leucovorin calcium.
- Determine the disease-free survival of patients with stage III colorectal carcinoma, other refractory carcinomas, or metastatic adenocarcinomas of unknown primary site treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients with stage III colorectal carcinoma (post surgical resection) receive irinotecan IV over 1 hour on days 1-5 and days 8-12. Treatment repeats every 3 weeks for 2 courses. Beginning on week 7, patients receive pelvic irradiation, leucovorin calcium IV over 4 hours, and fluorouracil IV over 5-15 minutes beginning 1 hour into leucovorin calcium infusion on days 1-5. Treatment repeats every 3 weeks for a total of 2 courses. Patients with no evidence of disease may repeat the above 12-week block of chemotherapy without pelvic irradiation up to 4 times over 1 year.
Patients with stage IV colorectal carcinoma, other refractory carcinomas, or metastatic adenocarcinomas of unknown primary site receive the above 12-week block of chemotherapy (irinotecan, fluorouracil, and leucovorin calcium) with pelvic irradiation (if indicated). Pelvic irradiation patients with an unresected primary tumor undergo exploratory surgery 4-5 weeks after completion of radiotherapy, even in the absence of visible tumor regression. Radical resection is attempted to effect local control and control of long term symptoms related to the primary tumor. Patients with complete response (CR) or partial response (PR) after both chemotherapy and surgery repeat the above 12-week block of chemotherapy 3 times over 1 year in the absence of disease progression or unacceptable toxicity. Patients with CR or PR after chemotherapy but no response after surgery receive irinotecan IV over 1 hour on days 1-5 and days 8-12 every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable disease (SD) or progressive disease after 2 courses of irinotecan and SD, CR, or PR after surgery receive leucovorin calcium and fluorouracil as above every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 hydrochloride | Drug | – |
| leucovorin calcium | Drug | – |
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Response rate
Toxicity
Disease-free 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 26 Apr 2017.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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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.
Wayne Lee Furman, MD study chair
St. Jude Children's Research Hospital
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 fluorouracil, irinotecan hydrochloride and leucovorin calcium in people with Carcinoma of Unknown Primary and Colorectal Cancer, run by St. Jude Children's Research Hospital 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 26 Apr 2017. 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 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?
Response rate. The study lists 3 primary outcomes in all. 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 26 Apr 2017.