Bladder CancerPhase 1NCT00004095
Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
A Phase 1 study testing gemcitabine hydrochloride and irinotecan hydrochloride in people with Bladder Cancer and Breast Cancer, run by Northwestern University 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 and gemcitabine in treating patients who have unresectable or… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bladder Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- gemcitabine hydrochloride and irinotecan hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Oct 2008
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic or surgically unresectable solid tumor, having received the following maximum number of prior therapies for advanced disease:
- Bladder cancer - no more than 1 prior therapy
- Breast cancer - no more than 2 prior therapies
- Colorectal cancer - no more than 1 prior therapy
- Kidney cancer - no prior therapy
- Lung cancer - no more than 1 prior therapy
- Pancreatic cancer - no prior therapy
- Bidimensionally measurable disease outside a previously irradiated field
- At least 2 cm x 2 cm
- No known bone metastases
- CNS involvement allowed if successfully controlled by surgery or radiotherapy and not requiring corticosteroids
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL regardless of liver involvement secondary to tumor
- SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
- No known Gilbert's disease
Renal:
- Creatinine no greater than 1.8 mg/dL
- Calcium less than 12.0 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
- No congestive heart failure requiring therapy
Other:
- No active uncontrolled bacterial, viral (including HIV), or invasive fungal infection
- No psychiatric disorders that would prevent compliance
- No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- No history of seizures
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent sargramostim (GM-CSF)
- No concurrent immunotherapy
Chemotherapy:
- No prior irinotecan, topotecan, or gemcitabine
- Prior adjuvant chemotherapy allowed, if at least 1 year between last dose of adjuvant chemotherapy and recurrence of cancer
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy to less than 30% of bone marrow
- No prior whole pelvic radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611
About this study
Official title: Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With 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 and gemcitabine in treating patients who have unresectable or metastatic solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) and the principal toxicities of irinotecan and gemcitabine in patients with surgically unresectable or metastatic solid tumors.
- Determine if the principal toxicities and MTD of this combination regimen are affected by drug sequencing in this patient population.
- Determine the potential for gemcitabine to alter the pharmacokinetic characteristics when administered with irinotecan in these patients.
- Describe the influence effected by varying the administration sequence of this combination regimen in this patient population.
- Obtain preliminary data regarding efficacy of this combination regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan IV over 90 minutes followed by gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Once the maximum tolerated dose (MTD) is reached, patients receive subsequent doses of the inverse sequence of the combination drugs until a new MTD is determined.
Cohorts of 3-6 patients receive escalating doses of irinotecan and gemcitabine until the MTD is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.
- Conditions
- Bladder Cancer, Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer
- Being tested
- gemcitabine hydrochloride, irinotecan hydrochloride
- Keywords
- stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV renal cell cancer, recurrent renal cell cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, recurrent bladder cancer, stage IV bladder cancer, stage IV non-small cell lung cancer, stage IV pancreatic cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Kidney Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Carcinoma, Non-Small-Cell Lung
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 Plus Gemcitabine | Experimental | Not described Receives: Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startAug 1999
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Al B. Benson, MD, FACP, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004095
- Sponsor's protocol ID
- NU 98X3
- Other IDs
- NU-98X3, P-UPJOHN-976475157, NCI-G99-1588
- Status last verified
- Apr 2017
- First submitted
- 10 Dec 1999
- Last updated
- 18 Apr 2017
- Results posted
- No
Publications
Wisinski KB, Mulcahy MF, Newman S, et al.: A phase I study of irinotecan and gemcitabine in solid tumors. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-140, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00004095
- Acronym / sponsor ID
- NU 98X3
- Conditions
- Bladder Cancer, Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer
- Keywords
- stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1999
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 May 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 and gemcitabine in treating patients who have unresectable or metastatic solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) and the principal toxicities of irinotecan and gemcitabine in patients with surgically unresectable or metastatic solid tumors.
- Determine if the principal toxicities and MTD of this combination regimen are affected by drug sequencing in this patient population.
- Determine the potential for gemcitabine to alter the pharmacokinetic characteristics when administered with irinotecan in these patients.
- Describe the influence effected by varying the administration sequence of this combination regimen in this patient population.
- Obtain preliminary data regarding efficacy of this combination regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan IV over 90 minutes followed by gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Once the maximum tolerated dose (MTD) is reached, patients receive subsequent doses of the inverse sequence of the combination drugs until a new MTD is determined.
Cohorts of 3-6 patients receive escalating doses of irinotecan and gemcitabine until the MTD is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan Plus Gemcitabine | Experimental | Drug: gemcitabine hydrochloride, Drug: irinotecan hydrochloride |
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 |
|---|---|---|
| gemcitabine hydrochloride | Drug | Irinotecan Plus Gemcitabine |
| irinotecan hydrochloride | Drug | Irinotecan Plus Gemcitabine |
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 18 Apr 2017.
- Results publicationWisinski KB, Mulcahy MF, Newman S, et al.: A phase I study of irinotecan and gemcitabine in solid tumors. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-140, 2007.
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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.
Al B. Benson, MD, FACP study chair
Robert H. Lurie Cancer Center
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 Bladder Cancer and Breast Cancer, run by Northwestern University 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 18 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 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 NCT00004095, which also lists 1 linked publication.
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 18 Apr 2017.