A Phase 1 interventional study of filgrastim and cisplatin in Fallopian Tube Cancer, Ovarian Cancer and Peritoneal Cavity Cancer, sponsored by City of Hope Medical Center. Completed. Open to female participants aged Up to 60 Years. Per ClinicalTrials.gov, last updated 2014-10-07.
Sponsored by City of Hope Medical Center · Phase 1, Interventional, and Treatment
RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cyclophosphamide, paclitaxel, melphalan, and cisplatin, followed by an autologous peripheral stem cell transplant in treating patients with stage III, stage IV, or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
OBJECTIVES:
OUTLINE: This is a dose-escalation study of topotecan hydrochloride.
Patients undergo surgical placement of an intraperitoneal (IP) catheter. Tumor biopsies are obtained during surgery for laboratory analysis of molecular determinants of apoptosis (including p53 status, p21 gene expression, bcl-2 gene expression, bcl-2/bax ratio) and molecular determinants of DNA damage and repair (including expression levels of ERCC1 and MDR1, and HER2/neu expression by immunohistochemistry). The extent of apoptosis is also assessed using the TdT assay.
Patients undergo daily blood sample collection during topotecan hydrochloride administration for pharmacokinetic studies. Patients treated at the maximum tolerated dose of topotecan hydrochloride undergo additional blood sample collections for pharmacokinetic studies.
After completion of study therapy, patients are followed every 3 months.
720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.
This study's enrollment of 8 is below the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.
Browse Fallopian Tube Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 182 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial carcinoma, primary peritoneal cavity carcinoma, or epithelial carcinoma of the fallopian tubes, meeting 1 of the following criteria:
Stage III or IV disease that was treated with initial therapy comprising a standard platinum-containing regimen
Responding recurrent disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Toxicity
Tumor response
Reason patient is removed from study
Disease progression
Overall survival
Progression-free survival
Time to progression
No study locations are listed for this record.
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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City of Hope Medical Center