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

NCT00466960 | Completed Phase 2 Results

• 2 other identifiers: 6168NCI-2010-00556
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Brenner Tumor; Fallopian Tube Cancer; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mixed Epithelial Carcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Undifferentiated Adenocarcinoma; Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (2)

• Time to Progression

  Median time to progression

  Up to 5 years

• Response Rate

  Number of patients achieving a complete or partial response.

  Up to 5 years

Secondary Outcomes (4)

• Correlation Between Circulating Monocytes and Time to Progression

  Up to 5 years

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

  Up to 5 years

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

  Up to 5 years

• Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens

  Up to 5 years

Study Arms (1)

Treatment (colony stimulating factor and chemotherapy)

EXPERIMENTAL

INDUCTION 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.

Biological: sargramostim; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Other: laboratory biomarker analysis; Other: immunologic technique

Interventions

sargramostim BIOLOGICAL

Given SC

Also known as: GM-CSF, Leukine, Prokine

Treatment (colony stimulating factor and chemotherapy)

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Given IV

Also known as: ABI-007, nab paclitaxel, nab-paclitaxel, nanoparticle albumin-bound paclitaxel

Treatment (colony stimulating factor and chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (colony stimulating factor and chemotherapy)

immunologic technique OTHER

Correlative studies

Also known as: immunological laboratory methods, laboratory methods, immunological

Treatment (colony stimulating factor and chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Brenner Tumor; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; Taxes; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Immunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Neoplasms by Site; Fallopian Tube Diseases; Carcinoma; Endocrine Gland Neoplasms

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Investigative Techniques

Results Point of Contact

• Title: Barbara Goff
• Organization: Seattle Cancer Care Alliance

bgoff@u.washington.edu

206-543-3668

Study Officials

• Barbara Goff

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: May 1, 2006
• Primary Completion: July 1, 2011
• Last Updated: August 28, 2017
• Results First Posted: August 28, 2017

Record last verified: 2017-07

Locations

US (1)