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

Completed · Phase 2

Conditions studied: 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

In brief

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

Key facts

Study ID: NCT00466960
Run by: University of Washington
People needed: 21
Starts: 2006-05-01
Last updated by the study team: 2017-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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