Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00054288
Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
A Phase 1 study testing gemcitabine hydrochloride 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with gemcitabine in treating patients who have refractory advanced… 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?
- gemcitabine hydrochloride and irinotecan hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Jun 2009
- 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 or cytologically confirmed advanced solid tumor that is refractory to prior treatment
- Considered incurable with other modalities
- Measurable or evaluable disease
- The following are not considered measurable or evaluable:
- Bone metastases
- Pleural, pericardial, or peritoneal effusions
- Irradiated lesions (unless progression is documented after radiotherapy)
- Metastatic disease that has been followed using serum tumor markers allowed
- No symptomatic brain metastases
- Brain metastases may not be sole site of metastatic disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 12 weeks
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- AST and ALT no greater than 1.5 times normal
- Bilirubin no greater than 1.5 mg/dL
- No clinically apparent jaundice
Renal
- Creatinine no greater than 1.6 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- Cardiac function normal
- No uncontrolled heart disease
- No myocardial infarction within the past 3 months
- No congestive heart failure
- No unstable or uncontrolled angina
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No active infection requiring systemic therapy
- No uncontrolled seizures
- No uncontrolled diabetes mellitus
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior gemcitabine
- No prior camptothecin compounds
- Prior irinotecan allowed
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 14 days since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- More than 30 days since prior clinical trial participation
- No other concurrent investigational medications
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: Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors.
- Determine the antitumor activity and toxicity of this regimen in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
- Determine the optimal dose and time interval for this regimen in these patients.
OUTLINE: This is an open-label, non-randomized, dose-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
- Being tested
- gemcitabine hydrochloride, 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 posted6 Feb 2003 (estimated)
- Study startAug 2001
- Primary completionMay 2003
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Non-randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Nithya Ramnath, MD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054288
- Sponsor's protocol ID
- CDR0000270343
- Other IDs
- RPCI-DS-01-18
- Status last verified
- Jan 2014
- First submitted
- 5 Feb 2003
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00054288
- Acronym / sponsor ID
- CDR0000270343
- 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
- Aug 2001
- Primary completion
- May 2003 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Feb 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors.
- Determine the antitumor activity and toxicity of this regimen in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
- Determine the optimal dose and time interval for this regimen in these patients.
OUTLINE: This is an open-label, non-randomized, dose-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
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 |
|---|---|---|
| gemcitabine hydrochloride | 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 13 Jan 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.
Nithya Ramnath, MD 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 gemcitabine hydrochloride 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 13 Jan 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 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?
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 13 Jan 2014.