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Advanced CancerPhase 1NCT01113476

Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies

A Phase 1 study testing Nab-paclitaxel, Bevacizumab and Gemcitabine in people with Advanced Cancer, run by M.D. Anderson 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
Nab-paclitaxel, Bevacizumab and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteUnited States
Study dates
27 Apr 2010to 12 Aug 2022
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

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase I Study of Combination of Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies

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.

Read the detailed description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of a combination of nab-paclitaxel, gemcitabine, and bevacizumab based on when you joined this study. All participants will receive the same dose level of gemcitabine. However, the first group of participants will receive the lowest dose level of nab-paclitaxel and bevacizumab. Each new group will receive a higher dose for one of the drugs than the group before it, if no intolerable side effects were seen. The other drug may be at the same dose or a lower dose. This will continue until the highest tolerable dose of combination of nab-paclitaxel, gemcitabine, and bevacizumab is found. Up to 15 dose levels of the study drug combination will be tested. Three (3) to 4 participants will be enrolled at each dose level.

Once the highest tolerated dose is found, up to 10 more participants will be added at that dose level. This is called an expansion group.

Study Drug Administration:

On Days 1, 8, and 15 of each 28-day cycle, you will receive nab-paclitaxel and gemcitabine by vein over about 90 minutes total. Also, if the first dose is well tolerated, you may be given the remaining doses of nab-paclitaxel and gemcitabine at home.

On Days 1 and 15 of each cycle, you will receive bevacizumab by vein over about 60 minutes. Also, if the first dose is well tolerated, you may be given the remaining doses of bevacizumab at home.

Study Visits:

Each week during Cycle 1:

  • Your medical history will be recorded.
  • Blood (about 2 teaspoons) and urine will be collected for routine tests.
  • Blood (about 2-5 teaspoons) will be drawn to test for fat levels in the blood. You will need to fast for at least 4 hours before this blood draw.
  • Your performance status will be recorded.
  • You will be asked about any drugs you may be taking and if you had any side effects from them.
  • You will have urine tests performed to check for high levels of protein in your urine (a known side effect of bevacizumab).

On Day 1 and 8 of Cycle 1, you will have a physical exam, including measurement of your weight and vital signs.

During Week 1 of Cycles 2 and beyond:

  • Your medical history will be recorded.
  • You will have a physical exam, including measurement of your weight and vital signs.
  • Blood (about 2 teaspoons) and urine will be collected for routine tests.
  • Blood (about 2-5 teaspoons) will be drawn to test for fat levels in the blood. You will need to fast for at least 4 hours before this blood draw.
  • Blood (about 2 teaspoons) will be drawn to see how well your blood clots and how long it takes for your blood to clot.
  • Your performance status will be recorded.
  • You will be asked about any drugs you may be taking and if you had any side effects from them.
  • Females who are able to become pregnant must have a negative blood (about 1 teaspoon) pregnancy test.

During Weeks 2 and 4 of Cycles 2 and beyond:

  • Your performance status will be recorded.
  • You will be asked about any drugs you may be taking and if you had any side effects from them.
  • Blood (about 2 teaspoons) will be collected for routine tests.

During Week 3 of Cycles 2 and beyond:

  • Your medical history will be recorded.
  • You will have a physical exam, including measurement of your weight and vital signs
  • Blood (about 2 teaspoons) and urine will be collected for routine tests.
  • Blood (about 2-5 teaspoons) will be drawn to test for fat levels in the blood. You will need to fast for at least 4 hours before this blood draw.
  • Blood (about 2 teaspoons) will be drawn to see how well your blood clots and how long it takes for your blood to clot.
  • Your performance status will be recorded.
  • You will be asked about any drugs you may be taking and if you had any side effects from them.

At the end of every 2 cycles (Cycles 2, 4, 6, and so on), you will have an x-ray, CT scan, PET scan, or MRI scan to check the status of the disease. If you have disease in your bones, a bone scan may also be done.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.

You may chose to stop taking the study drugs at any time. You should tell the study doctor right away if you are thinking about stopping your participation in this study. The study doctor will talk to you about how to safely stop taking the study drugs.

This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of certain types of breast cancer, non-small cell lung cancer, pancreatic cancer, and ovarian cancer. Bevacizumab is FDA approved and commercially available for the treatment of colorectal, breast, lung, and brain cancer. Nab-paclitaxel is FDA approved and commercially available for the treatment of breast cancer. The combination of these drugs is investigational.

Up to 120 patients will take part in this study, but this may be increased at a later time. All will be enrolled at MD Anderson.

Conditions
Advanced Cancer
Keywords
Advanced Malignancies, Nab-paclitaxel, Gemcitabine, Bevacizumab

What participants receive

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

  • Nab-paclitaxelDrug

    Also called Paclitaxel, Abraxane, ABI-007

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

  • BevacizumabDrug

    Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

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

  • GemcitabineDrug

    Also called Gemcitabine Hydrochloride, Gemzar

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

Study groups in NCT01113476
Study groupRoleWhat they receive
Nab-paclitaxel, Gemcitabine + BevacizumabExperimentalStarting doses of Nab-paclitaxel 50 mg/m^2, Bevacizumab 5 mg/kg + fixed dose of Gemcitabine 1000 mg/m^2
Receives: Drug: Nab-paclitaxel; Drug: Bevacizumab; Drug: Gemcitabine

What is being measured

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

  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.

    Measured: With each 28 day cycle

Secondary outcomes (1)

  1. Response Rate

    Patients with lymphoma measured per WHO criteria, all others evaluated with RECIST (version 1.1) criteria. Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension. Best Response: Measurement of longest dimension of each lesion size is required for follow-up. Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Partial Response (PR): At least 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference baseline sum of LD. Stable Disease (SD): Stable disease defined as any condition not meeting above criteria. Progressive Disease (PD): At least a 20% increase in sum of LD of target lesions taking as reference smallest sum LD or appearance of new lesions after study entry.

    Measured: After 2, 28 day cycles

Timeline

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

  1. First posted30 Apr 2010 (estimated)
  2. Study start27 Apr 2010
  3. Primary completion12 Aug 2022
  4. Study completion12 Aug 2022

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
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01113476
Sponsor's protocol ID
2009-0855
Other IDs
NCI-2011-02061
Status last verified
Aug 2022
First submitted
28 Apr 2010
Last updated
2 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 29695765

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nab-paclitaxel, Bevacizumab and Gemcitabine in people with Advanced Cancer, run by M.D. Anderson 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?

The sponsor lists 7 inclusion and 13 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 2 Sep 2022. 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?

Maximum Tolerated Dose (MTD) of Gemcitabine, Nab-Paclitaxel and Bevacizumab (time frame: With each 28 day cycle). 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 NCT01113476, which also lists 1 linked publication.

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 2 Sep 2022.

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