Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Metastatic Solid Tumors
This study has been completed.
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00520000
First received: August 21, 2007
Last updated: March 5, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: Carboplatin Drug: Abraxane |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors |
Resource links provided by NLM:
Further study details as provided by UNC Lineberger Comprehensive Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) of Abraxane [ Time Frame: 28 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To determine if there is any correlation to toxicity based on the order Abraxane and carboplatin are adminstered
| Enrollment: | 47 |
| Study Start Date: | December 2004 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Weekly Arm
Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle
|
Drug: Carboplatin
standard dose of area under the curve (AUC) AUC of 6 in all arms
Other Name: Paraplatin
Drug: Abraxane
75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle
Other Name: Paclitaxil
|
|
Experimental: Every 3 week Arm
Carboplatin day 1, abraxane day 1, every 21 day cycle
|
Drug: Carboplatin
standard dose of area under the curve (AUC) AUC of 6 in all arms
Other Name: Paraplatin
Drug: Abraxane
180mg/m2 - 340mg/m2, repeated every 21 days
Other Name: Paclitaxil
|
|
Experimental: Arm C
Carboplatin day 1, abraxane day 1, 8 every 21 day cycle
|
Drug: Carboplatin
standard dose of area under the curve (AUC) AUC of 6 in all arms
Other Name: Paraplatin
Drug: Abraxane
100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle
Other Name: Paclitaxil
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria:
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
- Have a disease for which there is no defined standard therapy
Exclusion criteria:
- Symptomatic brain metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
- 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
Exclusion criteria:
- 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
- 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00520000 History of Changes |
| Obsolete Identifiers: | NCT00254098 |
| Other Study ID Numbers: | LCCC0412, CDR0000561620 |
| Study First Received: | August 21, 2007 |
| Last Updated: | March 5, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013