Phase 2
Completed N=21
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
Brenner Tumor · Fallopian tube cancer · Ovarian Cancer · Peritoneal Cavity Cancer
Source: ClinicalTrials.gov NCT00466960 ↗
Enrolled (actual)
21
Serious AEs
9.5%
Results posted
Aug 2017
Primary outcomePrimary: Time to Progression — 4.07 months
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
4.07 | — |
| PRIMARY Response Rate |
15 | — |
| SECONDARY Correlation Between Circulating Monocytes and Time to Progression |
20.75; 12.75 | — |
| SECONDARY Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration |
1.543; 1.996; 0.2465; 0.3743 | — |
| SECONDARY Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens |
0.5056; 0.8496; 0.8269; 0.3676; -0.02268; -0.0817 | — |
| SECONDARY Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens |
-0.08759; -0.1818; -0.1071 | — |
Eligibility Criteria
Inclusion Criteria
- 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 = 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
Data sourced from ClinicalTrials.gov (NCT00466960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.