Breast CancerPhase 1NCT00003690
Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing alvocidib, carboplatin and cisplatin in people with Breast Cancer and Melanoma (Skin), run by Mayo Clinic 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 flavopiridol plus cisplatin or carboplatin in treating patients who have advanced solid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Melanoma (Skin), Prostate Cancer
- What is being tested?
- alvocidib, carboplatin and cisplatin
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1998to Sep 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 confirmed unresectable advanced solid tumor for which no standard therapy exists that is potentially curative or definitely capable of extending life expectancy
- Biopsy confirmation of recurrent tumors required, unless sole site of disease is inaccessible bony and/or pulmonary metastases
- Eligible solid tumors include, but not are limited to, prostate cancer, breast cancer, or melanoma
- No lymphoma
- No CNS metastases
- Patients with primary brain tumors are eligible if they are not receiving antiepileptic medication(s) but are receiving stable doses of corticosteroids
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Not specified
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- See Disease Characteristics
- At least 12 weeks
Hematopoietic:
- WBC at least 3,500/mm^3
- Absolute neutrophil count at least 1,700/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
Hepatic:
- Bilirubin within upper limit of normal (ULN)
- AST and ALT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No New York Heart Association class III or IV heart disease
- No history of angina
Neurologic:
- No grade 2 or greater peripheral neuropathy
- No seizure disorder
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since prior biologic therapy
- No concurrent immunotherapy
Chemotherapy:
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Flavopiridol in Combination With Cisplatin in Patients With Advanced Malignancies
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 flavopiridol plus cisplatin or carboplatin in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of flavopiridol and cisplatin in patients with advanced solid tumors. (Part 1)
- Determine the MTD of carboplatin when combined with flavopiridol in another group of patients with advanced solid tumors. (Part 2)
- Determine the toxic effects of these regimens in this patient population.
- Determine the objective clinical response in patients treated with this regimen.
- Determine the pharmacokinetics of these regimens in this patient population.
OUTLINE: This is a dose-escalation study of flavopiridol and cisplatin (part 1), followed by a dose-escalation study of carboplatin (part 2).
- Part 1: Patients receive flavopiridol IV over 24 hours. Two weeks later, patients receive cisplatin IV over 2 hours immediately followed by flavopiridol IV over 24 hours. Treatment with cisplatin/flavopiridol continues every 3 weeks in the absence of unacceptable toxicity or disease progression.
Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin. Cohorts of 3-6 patients receive escalating doses of flavopiridol and then cisplatin until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
- Part 2: Additional patients are accrued for part 2. Those patients receive carboplatin IV over 30 minutes immediately followed by flavopiridol IV over 24 hours. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of carboplatin until the MTD is determined. The MTD is defined as in part 1.
PROJECTED ACCRUAL: Approximately 36-48 patients will be accrued for this study within 2 years.
- Conditions
- Breast Cancer, Melanoma (Skin), Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- alvocidib, carboplatin, cisplatin
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, stage IV melanoma, recurrent melanoma, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Breast Neoplasms, Melanoma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alvocidibDrug
carboplatinDrug
cisplatinDrug
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 startDec 1998
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Keith C. Bible, MD, PhD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003690
- Sponsor's protocol ID
- CDR0000066793
- Other IDs
- U01CA069912, P30CA015083, 950101, 276-97
- Status last verified
- Aug 2011
- First submitted
- 1 Nov 1999
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Flavopiridol in Combination With Cisplatin in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00003690
- Acronym / sponsor ID
- CDR0000066793
- Conditions
- Breast Cancer, Melanoma (Skin), Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, stage IV melanoma, recurrent melanoma, unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 1998
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (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 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 flavopiridol plus cisplatin or carboplatin in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of flavopiridol and cisplatin in patients with advanced solid tumors. (Part 1)
- Determine the MTD of carboplatin when combined with flavopiridol in another group of patients with advanced solid tumors. (Part 2)
- Determine the toxic effects of these regimens in this patient population.
- Determine the objective clinical response in patients treated with this regimen.
- Determine the pharmacokinetics of these regimens in this patient population.
OUTLINE: This is a dose-escalation study of flavopiridol and cisplatin (part 1), followed by a dose-escalation study of carboplatin (part 2).
- Part 1: Patients receive flavopiridol IV over 24 hours. Two weeks later, patients receive cisplatin IV over 2 hours immediately followed by flavopiridol IV over 24 hours. Treatment with cisplatin/flavopiridol continues every 3 weeks in the absence of unacceptable toxicity or disease progression.
Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin. Cohorts of 3-6 patients receive escalating doses of flavopiridol and then cisplatin until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
- Part 2: Additional patients are accrued for part 2. Those patients receive carboplatin IV over 30 minutes immediately followed by flavopiridol IV over 24 hours. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of carboplatin until the MTD is determined. The MTD is defined as in part 1.
PROJECTED ACCRUAL: Approximately 36-48 patients will be accrued for this study within 2 years.
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 |
|---|---|---|
| alvocidib | Drug | – |
| carboplatin | Drug | – |
| cisplatin | 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 3 Aug 2011.
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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.
Keith C. Bible, MD, PhD study chair
Mayo Clinic
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 alvocidib, carboplatin and cisplatin in people with Breast Cancer and Melanoma (Skin), run by Mayo Clinic 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 3 Aug 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?
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 3 Aug 2011.