AzTrials
AzTrials

Brenner TumorPhase 2NCT00466960

Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy

A Phase 2 study testing sargramostim, paclitaxel albumin-stabilized nanoparticle formulation and laboratory biomarker analysis in people with Brenner Tumor and Fallopian Tube Cancer, run by University of Washington 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
Search all trials

Trial summary

RATIONALE: Colony stimulating factors, such as sargramostim (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing and may also increase the number of immune cells found in bone marrow or peripheral blood and help the immune system recover from the side effects of chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sargramostim, paclitaxel albumin-stabilized nanoparticle formulation and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
May 2006to Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 must have histologically proven epithelial ovarian, fallopian tube or primary peritoneal malignancies, excluding tumors of low malignant potential (borderline)
  • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified
  • Patients must have either primary platinum refractory or resistant carcinoma or secondary platinum resistant disease:
  • Primary platinum refractory disease is defined as progression of disease on initial platinum-based chemotherapy or persistent disease at the conclusion of the initial platinum-based chemotherapy course associated with the primary debulking surgery.
  • Primary platinum resistant disease is defined as recurrence of carcinoma within 6 months (+ 14 days) of completion of initial platinum-based chemotherapy associated with the primary debulking surgery. (The 14 day window is to allow study entry for those patients where evidence clearly suggests that had an assessment been made early the patient would have met the 6 month time line. This will be determined by the study principal investigator [P.I.])
  • Secondary platinum resistant disease is defined as meeting any one of the listed criteria during or following a subsequent platinum containing regimen.
Show all 13Show fewer
  • Patients must have an elevated serum cancer antigen (CA)125 on two occasions greater than 7 days apart
  • Absolute neutrophil count >= 1500/uL
  • Platelets >= 100,000/uL
  • Creatinine =< 2.0 mg/dL
  • Total bilirubin =< 1.5 mg/dL (unless history of Gilbert's disease)
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x upper limit of normal (ULN) or < 5 x ULN with documented report of hepatic metastases
  • Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy; at least three weeks must have elapsed since prior chemotherapy or radiation therapy

Who cannot join

  • Patient has an allergic history to paclitaxel or GM-CSF, not manageable by pre-medication and/or slow drug infusion
  • Patient has poorly controlled arrhythmias or unstable coronary artery disease or has had a myocardial infarction within the last six months
  • Patient with active pulmonary edema or pleural effusion
  • Active infection requiring IV antibiotics
  • Patient currently requires lithium, (due to drug interaction with GM-CSF [Leukine])
  • Patient currently presents with a neurotoxicity > Grade 1
  • Women of childbearing potential
  • Patients with a history of other invasive malignancies, within the previous 5 years are excluded, with the exception of non-melanoma skin cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) With Weekly Protein Bound Paclitaxel (Abraxane™) as Chemoimmunotherapy for Platinum-Refractory/Resistant Epithelial Ovarian, Primary Peritoneal and Fallopian Tube Cancer

RATIONALE: Colony stimulating factors, such as sargramostim (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing and may also increase the number of immune cells found in bone marrow or peripheral blood and help the immune system recover from the side effects of chemotherapy. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to previous chemotherapy

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether chronic GM-CSF administration during and after cytotoxic chemotherapy with paclitaxel albumin-stabilized nanoparticle formulation can induce a longer remission than experienced in the most recent platinum-containing regimen.

SECONDARY OBJECTIVES:

  1. To determine the extent to which chronic GM-CSF administration can increase the number of activated monocytes in patients with advanced stage epithelial ovarian cancer.

II. To determine the extent to which chronic GM-CSF administration can increase the number and activation state of peripheral circulating antigen presenting cells, such as dendritic cells and activated monocytes, in patients with advanced epithelial ovarian cancer.

III. To determine the extent to which chronic GM-CSF administration can increase the number and functional status of T cells that recognize tumor specific antigens in patients with advanced stage epithelial ovarian cancer.

IV. To determine the extent to which chronic GM-CSF administration can increase the number and functional status of antigen specific T cells that recognize foreign pathogens in patients with advanced stage epithelial ovarian cancer.

OUTLINE:

INDUCTION THERAPY: Patients receive GM-CSF subcutaneously (SC) once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 6 months and then every 3 months thereafter.

Being tested
sargramostim, paclitaxel albumin-stabilized nanoparticle formulation, laboratory biomarker analysis, immunologic technique
Medical subject headings
Brenner Tumor, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • sargramostimBiological

    Also called GM-CSF, Leukine, Prokine

    Given SC

  • paclitaxel albumin-stabilized nanoparticle formulationDrug

    Also called ABI-007, nab paclitaxel, nab-paclitaxel, nanoparticle albumin-bound paclitaxel

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • immunologic techniqueOther

    Also called immunological laboratory methods, laboratory methods, immunological

    Correlative studies

Study groups in NCT00466960
Study groupRoleWhat they receive
Treatment (colony stimulating factor and chemotherapy)ExperimentalINDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: sargramostim; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Other: laboratory biomarker analysis; Other: immunologic technique

What is being measured

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

  1. Time to Progression

    Median time to progression

    Measured: Up to 5 years

  2. Response Rate

    Number of patients achieving a complete or partial response.

    Measured: Up to 5 years

Secondary outcomes (4)

  1. Correlation Between Circulating Monocytes and Time to Progression

    Baseline median percentages of CD45+ cells made up of monocytes in complete responders (CR) compared to partial-responders, non-responders and those with stable disease (PR+NR+SD).

    Measured: Up to 5 years

  2. Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration

    Baseline median percentages of CD45+ cells made up of myeloid dendritic cells (mDC) and plasmacytoid dendritic cells (pDC) in complete responders (CR) compared to partial and non-responders (PR+NR+SD).

    Measured: Up to 5 years

  3. Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens

    Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.

    Measured: Up to 5 years

  4. Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens

    Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.

    Measured: Up to 5 years

Timeline

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

  1. First posted27 Apr 2007 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2011

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00466960
Sponsor's protocol ID
6168
Other IDs
NCI-2010-00556
Status last verified
Jul 2017
First submitted
25 Apr 2007
Last updated
28 Aug 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sargramostim, paclitaxel albumin-stabilized nanoparticle formulation and laboratory biomarker analysis in people with Brenner Tumor and Fallopian Tube Cancer, run by University of Washington 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 13 inclusion and 8 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 28 Aug 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Progression (time frame: Up to 5 years). 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 NCT00466960.

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 28 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in