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Chemotherapy Toxicity On Quality of Life in Older Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Not Recruiting
Trial ID: NCT01366183
Purpose
This trial studies the chemotherapy toxicity on quality of life in older patients with stage
I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or
fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may
help doctors plan better ways to treat cancer.
Official Title
Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Stanford Investigator(s)
Jonathan S. Berek, MD, MMSc
Laurie Kraus Lacob Professor
Eligibility
Inclusion Criteria:
- Eligible patients must have a histologically or cytologically confirmed diagnosis of
adenocarcinoma of the ovary, peritoneum, or fallopian tube either by surgery, biopsy,
fine-needle aspiration (FNA), paracentesis, or thoracentesis; a diagnosis of a
mucinous cancer must be made by biopsy only
- International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, and IV
are eligible
- Patients must have received no previous treatment for this malignancy other than
surgery
- Patients must be entered within eight weeks of confirmation of disease diagnosis by
surgery, biopsy, FNA, paracentesis or thoracentesis if there is no primary surgery,
and within twelve weeks of primary or staging surgery if patient received primary
surgery
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
- Platelets greater than or equal to 100,000/mcl
- Bilirubin less than or equal upper limit of normal (ULN)
- Creatinine less than or equal to 1.5 x ULN
- Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, 2 or
3
- Effective XX/XX/2014, only patients 75 years of age or older are eligible for
enrollment; (04/23/2012) (08/12/2013)
- Patients must have recovered from the effects of recent surgery
- Patients must be free of active infection requiring antibiotics
- Patients must have signed an approved informed consent and Health Insurance
Portability and Accountability Act (HIPAA)
- Patient and physician agree that they plan to conduct treatment according to Regimen 3
- Patient can read and understand sufficient English to be able to respond to questions
posed by the study instruments
Exclusion Criteria:
- Patients who have received previous treatment for this malignancy other than surgery
- Patients with other invasive malignancies whose previous cancer treatment
contraindicates this protocol therapy
- ?Borderline tumors? (tumors of low malignant potential) by surgery or biopsy are
excluded
- Patients with medical conditions that in the opinion of the investigator render
treatment on this protocol unsafe should be excluded
Intervention(s):
drug: carboplatin
drug: paclitaxel
procedure: assessment of therapy complications
biological: filgrastim
other: pharmacological study
other: questionnaire administration
other: quality-of-life assessment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061