Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00520000
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing Carboplatin and Abraxane in people with Unspecified Adult Solid Tumor, Protocol Specific, run by UNC Lineberger Comprehensive Cancer Center.
Trial summary
RATIONALE: Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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?
- Carboplatin and Abraxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Sep 2007
- 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
Who may be able to join
- Histologically or cytologically confirmed solid tumor
- Advanced or metastatic disease
- Measurable or evaluable disease
- Must meet 1 of the following criteria:
- Failed a standard therapy
- Not a candidate for standard therapy
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- Have a disease for which there is no defined standard therapy
- ECOG performance status 0-2
- Life expectancy ≥ 8 weeks
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 8.0 g/dL
- Total bilirubin normal
- Serum creatinine normal OR creatinine clearance ≥ 60 mL/min
- AST and ALT ≤ 2.5 x upper limit of normal
- Negative pregnancy test
Who cannot join
- Symptomatic brain metastases
- PATIENT CHARACTERISTICS:
- Pregnant or lactating
- Prior anaphylactic reaction or severe allergic reaction to paclitaxel and/or docetaxel
- Active infection that requires treatment with antibiotics for > 4 weeks
- Uncontrolled congestive heart failure
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- Symptomatic coronary artery disease or heart block
- Myocardial infarction within the past 3 months
- Peripheral neuropathy ≥ grade 2 from any cause
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or any other therapy for malignancy within the past 3 weeks
- No concurrent filgrastim, pegfilgrastim, or sargramostim during the first course of therapy
About this study
Official title: A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation together with carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects, the best way to give, and the best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin in treating patients with advanced or metastatic solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of paclitaxel albumin-stabilized nanoparticle formulation given once weekly for 3 weeks when administered with carboplatin given once every 4 weeks.
- Determine the MTD of paclitaxel albumin-stabilized nanoparticle formulation given once every 3 weeks when administered with carboplatin given once every 3 weeks.
- Determine the MTD of paclitaxel albumin-stabilized nanoparticle formulation given in weeks 1 and 2 when administered with carboplatin given once every 3 weeks.
- Evaluate sequence-dependent effects on toxicity and pharmacokinetics in the combination of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin.
Secondary
- Explore the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation given once weekly or once every 3 weeks.
OUTLINE: Patients are assigned to 1 of 3 treatment arms.
- Arm I: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients in arms I and II undergo blood sample collection periodically for pharmacokinetic studies.
After completion of study treatment, patients are followed at 30 days.
- Being tested
- Carboplatin, Abraxane
- 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.
CarboplatinDrug
Also called Paraplatin
standard dose of area under the curve (AUC) AUC of 6 in all arms
AbraxaneDrug
Also called Paclitaxil
75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle
AbraxaneDrug
Also called Paclitaxil
180mg/m2 - 340mg/m2, repeated every 21 days
AbraxaneDrug
Also called Paclitaxil
100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Weekly Arm | Active comparator | Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle Receives: Drug: Carboplatin; Drug: Abraxane |
| Every 3 week Arm | Experimental | Carboplatin day 1, abraxane day 1, every 21 day cycle Receives: Drug: Carboplatin; Drug: Abraxane |
| Arm C | Experimental | Carboplatin day 1, abraxane day 1, 8 every 21 day cycle Receives: Drug: Carboplatin; Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Abraxane
To determine the maximum tolerated dose (MTD) of Abraxane weekly days 1, 8, 15 with a carboplatin dose of AUC=6 given on day 1 of a 28 day cycle
Measured: 28 days
Maximum Tolerated Dose (MTD) of Abraxane given with Carboplatin
To determine the MTD of Abraxane given every 3 weeks with carboplatin given on day 1 of a 21 day cycle
Measured: 21 days
Sequence-dependent toxicity
To determine if there is any correlation to toxicity based on the order Abraxane and carboplatin are adminstered
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startDec 2004
- Primary completionMay 2006
- Study completionSep 2007
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 UNC Lineberger Comprehensive Cancer CenterThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas E. Stinchcombe, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520000
- Sponsor's protocol ID
- LCCC0412
- Other IDs
- CDR0000561620
- Status last verified
- Mar 2012
- First submitted
- 21 Aug 2007
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00520000
- Acronym / sponsor ID
- LCCC0412
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Primary completion
- May 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 23 Aug 2007 (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 paclitaxel albumin-stabilized nanoparticle formulation and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation together with carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects, the best way to give, and the best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin in treating patients with advanced or metastatic solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of paclitaxel albumin-stabilized nanoparticle formulation given once weekly for 3 weeks when administered with carboplatin given once every 4 weeks.
- Determine the MTD of paclitaxel albumin-stabilized nanoparticle formulation given once every 3 weeks when administered with carboplatin given once every 3 weeks.
- Determine the MTD of paclitaxel albumin-stabilized nanoparticle formulation given in weeks 1 and 2 when administered with carboplatin given once every 3 weeks.
- Evaluate sequence-dependent effects on toxicity and pharmacokinetics in the combination of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin.
Secondary
- Explore the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation given once weekly or once every 3 weeks.
OUTLINE: Patients are assigned to 1 of 3 treatment arms.
- Arm I: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients in arms I and II undergo blood sample collection periodically for pharmacokinetic studies.
After completion of study treatment, patients are followed at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weekly Arm | Active comparator | Drug: Carboplatin, Drug: AbraxaneCarboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle |
| Every 3 week Arm | Experimental | Drug: Carboplatin, Drug: AbraxaneCarboplatin day 1, abraxane day 1, every 21 day cycle |
| Arm C | Experimental | Drug: Carboplatin, Drug: AbraxaneCarboplatin day 1, abraxane day 1, 8 every 21 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed solid tumor
- Measurable or evaluable disease
- Must meet 1 of the following criteria:
- ECOG performance status 0-2
- Life expectancy ≥ 8 weeks
Key exclusion criteria (12 listed)
- Symptomatic brain metastases
- Pregnant or lactating
- Prior anaphylactic reaction or severe allergic reaction to paclitaxel and/or docetaxel
- Active infection that requires treatment with antibiotics for > 4 weeks
- Uncontrolled congestive heart failure
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 |
|---|---|---|
| CarboplatinAlso: Paraplatinstandard dose of area under the curve (AUC) AUC of 6 in all arms | Drug | Arm C, Every 3 week Arm, Weekly Arm |
| AbraxaneAlso: Paclitaxil75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle | Drug | Weekly Arm |
| AbraxaneAlso: Paclitaxil180mg/m2 - 340mg/m2, repeated every 21 days | Drug | Every 3 week Arm |
| AbraxaneAlso: Paclitaxil100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle | Drug | Arm C |
Primary outcome
Maximum Tolerated Dose (MTD) of Abraxane
Time frame: 28 days
To determine the maximum tolerated dose (MTD) of Abraxane weekly days 1, 8, 15 with a carboplatin dose of AUC=6 given on day 1 of a 28 day cycle
Maximum Tolerated Dose (MTD) of Abraxane given with Carboplatin
Time frame: 21 days
To determine the MTD of Abraxane given every 3 weeks with carboplatin given on day 1 of a 21 day cycle
Sequence-dependent toxicity
Time frame: 28 days
To determine if there is any correlation to toxicity based on the order Abraxane and carboplatin are adminstered
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 6 Mar 2012.
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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.
Thomas E. Stinchcombe, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carboplatin and Abraxane in people with Unspecified Adult Solid Tumor, Protocol Specific, run by UNC Lineberger Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. 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 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Abraxane (time frame: 28 days). 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 6 Mar 2012.