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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

Conditions

Fallopian Tube Cancer | Other Female Genital | Ovarian Cancer | Ovary | Primary Peritoneal Cavity Cancer

Trial Phase

Trial Purpose and Description

Trial Purpose

RATIONALE: Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.

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.


Participation Guidelines

Age:
70 Years and older
Gender:
Both

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • 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), or paracentesis
  • A diagnosis of a mucinous cancer must be made by biopsy only
  • International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, or IV are eligible
  • Patients must have received no previous treatment for this malignancy other than surgery
  • Patient must be entered within eight weeks of confirmation of disease diagnosis by surgery, biopsy, FNA or paracentesis, or within twelve weeks of primary or staging surgery if patient received primary surgery
  • Patient and physician agree that they plan to conduct treatment according to Regimen 1 or Regimen 2
  • "Borderline tumors" (tumors of low malignant potential) by surgery or biopsy are excluded

PATIENT CHARACTERISTICS:

  • GOG performance status of 0, 1, 2 or 3
  • No GOG performance status of 4
  • ANC = 1,500/mcL
  • Platelet count = 100,000/mcL
  • Bilirubin normal
  • Creatinine = 1.5 times upper limit of normal (ULN)
  • Patients must be free of active infection requiring antibiotics
  • Patient can read and understand sufficient English to be able to respond to questions posed by the study instruments
  • No patients with other invasive malignancies whose previous cancer treatment contraindicates this protocol therapy
  • No patients with medical conditions that in the opinion of the investigator render treatment on this protocol unsafe
  • Patients must have signed an approved informed consent and HIPAA
  • In signing the consent, patients must agree to provide blood samples from which plasma will be extracted to be tested for research purposes

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Patients must have recovered from the effects of recent surgery
Sponsor:
Gynecologic Oncology Group
Dates:
04/05/2012
Last Updated:
Study HIC#:
1202009650