Determinants of Age-Related Treatment Effectiveness in Ovarian Cancer

Inclusion Criteria:

- Participants must have one of the following: a) Histological or cytological diagnosis
of high-grade serous ovarian, fallopian, or peritoneal cancer, stage III or IV; b) In
the opinion of investigator, highly suspicious stage III or IV ovarian, fallopian, or
peritoneal cancer (histologically confirmed non-serous ovarian, fallopian, and
peritoneal cancers will be considered screening failures).

- At least one biopsiable lesion by CT/US or laparoscopy.

- Have not received previous treatment for ovarian cancer.

- Life expectancy of greater than 6 months.

- Eastern Cooperative Oncology Group (ECOG) performance status <3 (Karnofsky >60%).

- Must have adequate organ and marrow function.

- Deemed eligible for neo-adjuvant chemotherapy with carboplatin and paclitaxel and
surgery by their oncologist.

- Women of child-bearing potential must agree to use adequate contraception prior to
study entry and for the duration of study participation.

- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- Active second malignancy within last 2 years (except non-melanoma skin cancer or in
situ carcinomas.

- Prior treatment for ovarian cancer.

- Potential participants with known brain metastases will be excluded from this clinical
trial.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to carboplatin and paclitaxel.

- Known allergy to carboplatin, paclitaxel, or cremophor.

- Uncontrolled concomitant illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Women who are pregnant. Breastfeeding should be discontinued if the mother is treated
with carboplatin and paclitaxel. These potential risks may also apply to other agents
used in this study.

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study because of possible pharmacokinetic interactions with carboplatin and
paclitaxel or other agents administered during the study.