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


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
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor


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

   - 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

   - 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

   - 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

   - Patients with medical conditions that in the opinion of the investigator render
   treatment on this protocol unsafe should be excluded


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

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