View Clinical Trial (Medical Research Study)
Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
| City: |
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Tulsa |
| State: |
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Oklahoma |
| Zip Code: |
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74136 |
| Conditions: |
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Fallopian Tube Cancer - Ovarian Cancer - Primary Peritoneal Cavity Cancer |
| Purpose: |
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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.
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| Study Summary: |
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OBJECTIVES:
Primary
- To determine whether the score on Instrumental Activities of Daily Living (IADL)
obtained at time of registration is associated with the ability of patients to complete
four courses of chemotherapy without dose reduction or a more than 7-day delay.
- To estimate by regimen the percentage of patients who are able to complete four courses
of chemotherapy regardless of dose reductions and delays.
- To compare actual and calculated carboplatin area under the curve (AUC) in this patient
population.
Secondary
- To describe the percentage of patients who are entered after primary surgery versus
those entered to receive primary or neoadjuvant chemotherapy, the percentage of
patients who are treated with each allowed regimen, and the percentage of patients who
eventually receive surgery in the primary chemotherapy group.
- To determine whether the need for assistance with IADLs at time of registration is
associated with choice of chemotherapy regimen (in both primary chemotherapy and
primary surgery patients).
- To explore whether age, baseline scores on the geriatric measures (functional status,
nutritional status, or co-morbidity) and quality-of-life (QOL) are correlated with
likelihood of completing four courses of chemotherapy without dose reduction or a more
than 7-day delay.
- To explore reasons for and timing of dose reductions and delays.
- To describe toxicities, pre-/post-chemotherapy QOL, and pre-/post-chemotherapy scores
on geriatric measures in this patient population.
Tertiary
- To explore potential relationships of carboplatin AUC, paclitaxel clearance, and
paclitaxel time above a plasma concentration of 0.05 mcM to nadir neutrophil and
platelet counts during course 1 of treatment.
- To explore the association between baseline IADL and survival.
- To explore the association between IADL and the functional well-being (FWB) subscale in
the Functional Assessment of Cancer Therapy - Ovary (FACT-O).
OUTLINE: Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim
(regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their
physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy
at the discretion of treating physician.
Patients undergo blood sample collection at baseline and periodically during course 1 for
pharmacokinetic studies.
Patients' quality of life is assessed by the Functional Assessment of Cancer Therapy - Ovary
(FACT-O), the Functional Assessment of Cancer Treatment - Neurotoxicity (FACT-Ntx subscale),
the Instrumental Activities of Daily Living (IADL), and the Ability to Complete Social
Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after
completion of course 4. Nutritional status, such as body mass index and weight loss, and
comorbidity and hearing impairment are also assessed.
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| Criteria: |
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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
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| NCT ID: |
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NCT01366183 |
| Primary Contact: |
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Study Chair
Vivian von Gruenigen, MD
Case Comprehensive Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Tulsa, Oklahoma 74136
United States
Robert S. Mannel, MD
Phone: 405-271-8787
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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