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

Status unconfirmed

Conditions studied: Stage I Ovarian Cancer AJCC v6 and v7, Stage IA Fallopian Tube Cancer AJCC v6 and v7, Stage IB Fallopian Tube Cancer AJCC v6 and v7, Stage IC Fallopian Tube Cancer AJCC v6 and v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage IIA Fallopian Tube Cancer AJCC v6 and v7, Stage IIB Fallopian Tube Cancer AJCC v6 and v7, Stage IIC Fallopian Tube Cancer AJCC v6 and v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7

In brief

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.

Key facts

Study ID

NCT01366183

Run by

Gynecologic Oncology Group

People needed

290

Starts

2011-08-15

Last updated by the study team

2021-09-30

Who can join

Age: 75 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Gynecologic Oncology Group of Arizona — Phoenix, Arizona, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• John Muir Medical Center-Concord Campus — Concord, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• Olive View-University of California Los Angeles Medical Center — Sylmar, California, United States
• Rocky Mountain Gynecologic Oncology PC — Englewood, Colorado, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• Middlesex Hospital — Middletown, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Stamford Hospital/Bennett Cancer Center — Stamford, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Gynecologic Oncology LLC — Newark, Delaware, United States
• Delaware Clinical and Laboratory Physicians PA — Newark, Delaware, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.