Diseases and Conditions Researched
Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
What is the purpose of this trial?
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
Click here for
detailed participation information for this trial.
|
Sponsor:
|
Gynecologic Oncology Group |
| Dates: |
June 2, 2011 |
| Last Updated: |
April 12, 2012 |
| Study HIC#: |
1202009650 |
| Clinicaltrials.gov ID: |
NCT01366183
|
Conditions
Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
Interventions Details
| Biological:
|
filgrastim |
| Drug:
|
carboplatin |
| Drug:
|
paclitaxel |
| Other:
|
pharmacological study |
| Other:
|
questionnaire administration |
| Procedure:
|
assessment of therapy complications |
| Procedure:
|
quality-of-life assessment |
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
Link
|
Sponsor:
|
Gynecologic Oncology Group |
| Dates: |
June 2, 2011 |
| Last Updated: |
April 12, 2012 |
| Study HIC#: |
1202009650 |
| Clinicaltrials.gov ID: |
NCT01366183
|