NCT00307255

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

April 4, 2012

Status Verified

April 1, 2012

Enrollment Period

1.1 years

First QC Date

March 24, 2006

Last Update Submit

April 2, 2012

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumorprotocol specificPaclitaxelAbraxaneGemcitabineGemzarPhase ILineberger

Outcome Measures

Primary Outcomes (2)

  • Dose Limiting Toxicity (DLT)

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

    21 days

  • 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

    1 year

Secondary Outcomes (1)

  • Radiographic Response to Treatment

    every 42 days

Interventions

gemcitabine hydrochlorideDRUG

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

Also known as: Gemzar
paclitaxel albumin-stabilized nanoparticle formulationDRUG

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)

Also known as: Abraxane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

GemcitabineTaxesAlbumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingEconomicsHealth Care Economics and OrganizationsPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Thomas E. Stinchcombe, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 27, 2006

Study Start

August 1, 2006

Primary Completion

September 1, 2007

Study Completion

October 1, 2008

Last Updated

April 4, 2012

Record last verified: 2012-04

Locations

US(1)