Trial Information

Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

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.