NCT01113476

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of Abraxane (nab-paclitaxel), Gemzar (gemcitabine), and Avastin (bevacizumab) that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2010

Longer than P75 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

Study Start

First participant enrolled

April 27, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2022

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

12.3 years

First QC Date

April 28, 2010

Last Update Submit

August 31, 2022

Conditions

Advanced Cancer

Keywords

Advanced MalignanciesNab-paclitaxelGemcitabineBevacizumab

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Gemcitabine, Nab-Paclitaxel and Bevacizumab

    A MTD is defined as the dose level below the dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) in the first cycle. DLT defined as any grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v4.0, even if expected and believed related to study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by the NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE v.4.0 that is attributable to therapy.

    With each 28 day cycle

Secondary Outcomes (1)

  • Response Rate

    After 2, 28 day cycles

Study Arms (1)

Nab-paclitaxel, Gemcitabine + Bevacizumab

EXPERIMENTAL

Starting doses of Nab-paclitaxel 50 mg/m\^2, Bevacizumab 5 mg/kg + fixed dose of Gemcitabine 1000 mg/m\^2

Drug: Nab-paclitaxelDrug: BevacizumabDrug: Gemcitabine

Interventions

Nab-paclitaxelDRUG

Starting dose of 50 mg/m\^2 on Day 1, 8 + 15 every 28 days (+/- 2 days)

Also known as: Paclitaxel, Abraxane, ABI-007
Nab-paclitaxel, Gemcitabine + Bevacizumab
BevacizumabDRUG

Starting dose of 5 mg/m\^2 on Day 1 + 15 every 28 days (+/- 2 days)

Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Nab-paclitaxel, Gemcitabine + Bevacizumab
GemcitabineDRUG

1000 mg/kg Day 1, 8 + 15 every 28 days (+/- 2 days)

Also known as: Gemcitabine Hydrochloride, Gemzar
Nab-paclitaxel, Gemcitabine + Bevacizumab

Eligibility Criteria

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

You may qualify if:

  • Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
  • Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
  • ECOG performance status \</= 2 (Karnofsky \>/= 60%).
  • Patients must have allowable organ and marrow function defined as: absolute neutrophil count \>/= 1,000/mL; platelets \>/=50,000/mL; creatinine \</= 3 X ULN; total bilirubin \</= 3.0; ALT(SGPT) \</= 5 X ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/dL.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies.

You may not qualify if:

  • Patients with hemoptysis within 28 days prior to entering the study.
  • Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.
  • Uncontrolled systemic vascular hypertension (Systolic blood pressure \> 140mmHg, diastolic blood pressure \> 90 mmHg on medication).
  • Pregnant or lactating women.
  • History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
  • History of hypersensitivity to gemcitabine.
  • History of hypersensitivity to nab-paclitaxel or paclitaxel.
  • Patients with clinically significant cardiovascular disease: Myocardial Infarction or unstable angina pectoris within the last 6 months, Class III/IV NYHA heart failure.
  • History of CVA within 6 months.
  • History of surgery within last 28 days.
  • Grade 3/4 proteinuria.
  • Nephrotic syndrome.
  • Incompletely healed wound.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Sen S, Kato S, Agarwal R, Piha-Paul S, Hess K, Karp D, Janku F, Fu S, Naing A, Pant S, Falchook G, Tang C, Wu X, Ye Y, Tsimberidou A, Subbiah V, Kurzrock R, Byers L, Westin S, Lim J, Bean S, Bass A, Nguyen L, Meric-Bernstam F, Hong D. Phase I study of nab-paclitaxel, gemcitabine, and bevacizumab in patients with advanced cancers. Br J Cancer. 2018 May;118(11):1419-1424. doi: 10.1038/s41416-018-0068-z. Epub 2018 Apr 26.

    PMID: 29695765DERIVED

Related Links

MeSH Terms

Interventions

130-nm albumin-bound paclitaxelPaclitaxelAlbumin-Bound PaclitaxelBevacizumabGemcitabine

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • David S. Hong, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

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

April 28, 2010

First Posted

April 30, 2010

Study Start

April 27, 2010

Primary Completion

August 12, 2022

Study Completion

August 12, 2022

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations

US(1)