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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00307255

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors

A Phase 1 study testing gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation in people with Unspecified Adult Solid Tumor, Protocol Specific, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation
How many people
18 participants
Where
1 siteUnited States
Study dates
Aug 2006to 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumors
  • Advanced metastatic disease
  • Measurable or evaluable disease
  • Must meet 1 of the following criteria:
  • Failed prior standard therapy
  • Not a candidate for standard therapy
  • Has a disease for which there is no defined standard therapy
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

  • ECOG functional status 0-2
  • Life expectancy ≥ 8 weeks
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Bilirubin normal
  • Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
  • AST and ALT ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • No prior anaphylactic reaction or severe allergic reaction to paclitaxel, docetaxel, or gemcitabine hydrochloride
  • No active infectious process that will require treatment with antibiotics for > 4 weeks
  • No uncontrolled congestive heart failure
  • No symptomatic coronary artery disease or heart block
  • No myocardial infarction within the past 3 months
  • No peripheral neuropathy ≥ grade 2 from any cause

PRIOR CONCURRENT THERAPY:

  • More than 3 weeks since prior chemotherapy, radiotherapy, or any other treatment
  • No prior radiotherapy to > 25% of bone marrow
  • No prior nitrosoureas
  • No more than 6 prior courses of alkylating agents
  • No more than 2 prior courses of mitomycin C
  • No more than 3 prior courses of cytotoxic therapy for metastatic disease
  • No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) during study course 1

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating patients with advanced metastatic solid tumors.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the dose-limiting toxicity and maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) in combination with gemcitabine hydrochloride in patients with advanced metastatic solid tumors.

Secondary

  • Evaluate the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane).

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) IV over 30 minutes on day 1 followed by gemcitabine hydrochloride 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.

Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients may be treated at the MTD.

After completion of study treatment, patients are followed at 30 days.

Being tested
gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation
Keywords
unspecified adult solid tumor, protocol specific, Paclitaxel, Abraxane, Gemcitabine, Gemzar, Phase I, Lineberger

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabine hydrochlorideDrug

    Also called Gemzar

    1000 mg/m2 on days 1 and 8 of each 21 day cycle

  • paclitaxel albumin-stabilized nanoparticle formulationDrug

    Also called Abraxane

    260 mg/m2 to 340 mg/m2 (dose will depend on when subject enters the study). Paclitaxel will be given on day 1 of each 21 day cycle (every 3 weeks)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (DLT)

    Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days)

    Measured: 21 days

  2. Maximum Tolerated Dose(MTD)

    If greater than or equal to 2 of 6 patients (33%) experience a DLT, then that dose level will be considered to have excessive toxicity and will = MTD

    Measured: 1 year

Secondary outcomes (1)

  1. Radiographic Response to Treatment

    Radiographic response will be measured and evaluated using RECIST criteria.

    Measured: every 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionSep 2007
  4. Study completionOct 2008

Resources

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00307255
Sponsor's protocol ID
LCCC 0520
Other IDs
CDR0000550136
Status last verified
Apr 2012
First submitted
24 Mar 2006
Last updated
4 Apr 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation in people with Unspecified Adult Solid Tumor, Protocol Specific, run by UNC Lineberger Comprehensive Cancer Center 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 4 Apr 2012. 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.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00307255.

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 4 Apr 2012.

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