Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00024141
Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing fluorouracil and irinotecan hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- fluorouracil and irinotecan hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 2001to Jan 2003
- Phase
- Phase 1
- 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
DISEASE CHARACTERISTICS:
- Histologically proven recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value
- Must have disease that can be safely and readily biopsied under local anesthesia (including, but not limited to, subcutaneous metastases, superficial lymph node metastases, or ascites)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST less than 2 times ULN
- Alkaline phosphatase less than 2 times ULN
- Lactic dehydrogenase less than 2 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- HIV negative
- No active uncontrolled bacterial, viral, or fungal infection
- No nonmalignant systemic disease that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No prior irinotecan
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy except small-port radiotherapy for local control
- No concurrent radiotherapy except small-port radiotherapy for local disease control (e.g., pain relief or impending fracture)
Surgery:
- See Disease Characteristics
- At least 2 weeks since prior major surgery
Other:
- No concurrent anticoagulants except warfarin or subcutaneous heparin
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: 5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients.
- Assess, in a preliminary manner, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose de-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.
- Being tested
- fluorouracil, irinotecan hydrochloride
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2003 (estimated)
- Study startMay 2001
- Primary completionSep 2002
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Roswell Park 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Patrick J. Creaven, MBBS, PhD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024141
- Sponsor's protocol ID
- CDR0000068895
- Other IDs
- RPCI-RP-01-01
- Status last verified
- Mar 2011
- First submitted
- 13 Sep 2001
- Last updated
- 7 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ramnath N, Creaven PJ, Khushalani N, et al.: Pilot studies of antimetabolites preceeded by irinotecan in advanced solid tumors. [Abstract] Eur J Cancer 38 (Suppl 7): S44-5, 2002.
Creaven PJ, Slocum HK, Toth K, et al.: Modulation of 5-fluorouracil by irinotecan in advanced solid tumors: a pilot study. [Abstract] Int J Cancer 100 (Suppl 13): A-O78, 94, 2002.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study
- ClinicalTrials.gov ID
- NCT00024141
- Acronym / sponsor ID
- CDR0000068895
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- May 2001
- Primary completion
- Sep 2002 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 20 Jun 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.
PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES:
- Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients.
- Assess, in a preliminary manner, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose de-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| fluorouracil | Drug | – |
| irinotecan hydrochloride | Drug | – |
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 7 Mar 2011.
- BackgroundRamnath N, Creaven PJ, Khushalani N, et al.: Pilot studies of antimetabolites preceeded by irinotecan in advanced solid tumors. [Abstract] Eur J Cancer 38 (Suppl 7): S44-5, 2002.
- Results publicationCreaven PJ, Slocum HK, Toth K, et al.: Modulation of 5-fluorouracil by irinotecan in advanced solid tumors: a pilot study. [Abstract] Int J Cancer 100 (Suppl 13): A-O78, 94, 2002.
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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.
Patrick J. Creaven, MBBS, PhD study chair
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fluorouracil and irinotecan hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Roswell Park Cancer Institute 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 7 Mar 2011. 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 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.
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?
On the ClinicalTrials.gov record for NCT00024141, which also lists 2 linked publications.
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 7 Mar 2011.