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A Phase II Study of Carboplatin and Paclitaxel as Neoadjuvant Chemotherapy Followed by Interval Cytoreduction in Women With Advanced Staged Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma for High-Risk Surgical Candidates or Patients Unlikely to be Optimally Surgically Cytoreduced

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Study of Carboplatin and Paclitaxel as Neoadjuvant Chemotherapy Followed by Interval Cytoreduction in Women With Advanced Staged Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma for High-Risk Surgical Candidates or Patients Unlikely to be Optimally Surgically Cytoreduced



- Determine whether at least 50% of patients with advanced ovarian epithelial, fallopian
tube, or primary peritoneal cavity cancer are able to achieve optimal cytoreduction (to
< 1 centimeter of remaining disease) after neoadjuvant chemotherapy comprising
paclitaxel and carboplatin.


- Determine the frequency and severity of toxicity associated with this regimen in
patients who are high-risk surgical candidates or in patients unlikely to achieve
optimal surgical cytoreduction.

- Determine if extreme drug resistance assay profiles change after neoadjuvant

- Determine how thrombospondin-1 (TSP-1), tumor protein 53 (p53), and tumor vessel
density change after administration of neoadjuvant chemotherapy.

- Assess the quality of life of patients receiving neoadjuvant chemotherapy.

- Obtain estimates of tumor response after administration of neoadjuvant chemotherapy.

- Determine whether serum cancer antigen 125 (CA-125) at the time of cytoreduction is
associated with the ability to optimally reduce the patients.

OUTLINE: This is an open-label study.

Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30
minutes on day 1. Treatment repeats every 3 weeks for up to 4 courses in the absence of
disease progression or unacceptable toxicity. Within 4-6 weeks after the fourth course of
chemotherapy, patients undergo interval cytoreductive surgery.

Patients who are unable to undergo surgery receive 2 additional courses of chemotherapy and
are re-evaluated for surgery after the sixth course of chemotherapy.

Within 4 weeks after surgery, patients receive 2 additional courses of chemotherapy.

Quality of life is assessed periodically.

Tumor samples are obtained via laparoscopic or percutaneous biopsy prior to beginning
chemotherapy and during interval cytoreduction. Tissue is examined by immunohistochemistry
staining for p53, TSP-1, microvessel density (CD31), angiogenesis, membrane protein BCL-2,
and multidrug resistant gene 1 (MDR-1). Gene array analysis and extreme drug resistant
assays are also performed.

After completion of study treatment, patients are followed every 3 months for 2 years.

Inclusion Criteria:

- Patients with histological diagnosis of epithelial ovarian, primary peritoneal, or
fallopian tube carcinoma for which no previous treatment has been given.

Patients with the following histological epithelial cell types are eligible:

- Serous adenocarcinoma

- Mucinous adenocarcinoma

- Clear cell adenocarcinoma

- Transitional cell

- Adenocarcinoma not otherwise specified

- Endometrioid adenocarcinoma

- Undifferentiated carcinoma

- Mixed epithelial carcinoma

- Malignant Brenner's tumor

- Measurable or non-measurable disease as defined by Solid Tumor Response Criteria
(RECIST) within 4 weeks of study entry

- High-risk surgical candidate

- Gynecologic Oncology Group (GOG) performance status 0-3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 1.5 mg/dL

- Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times ULN

- Life expectancy ≥ 12 weeks

Exclusion Criteria:

- Pregnant or nursing

- Positive pregnancy test -(Fertile patients must use effective nonhormonal
contraception during and for 3 months after completion of study treatment.)

- History of another neoplasm except for non-metastatic, non-melanoma skin cancers,
carcinoma in situ of the cervix, or cancer cured by surgery > 5 years prior to

- Septicemia, severe infection, acute hepatitis, or severe gastrointestinal bleeding,
defined as requiring blood transfusion or hospitalization at registration

- Unstable angina will not be eligible. Patients with evidence of abnormal cardiac
conduction (e.g. bundle branch block, heart block) are eligible if their disease has
been stable for the past six months.

- History of severe hypersensitivity or allergic reaction to study drugs, drugs
formulated in Cremophor EL^®, other platinol compounds, or mannitol

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy

Outcome Description:

These patients had their tumor(s) removed by surgery after receiving 4 cycles of chemotherapy to determine their response.

Outcome Time Frame:

Week 18 (After 4 cycles of chemotherapy)

Safety Issue:


Principal Investigator

Melissa A. Geller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

March 2009

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • ovarian clear cell cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • peritoneal cavity cancer
  • fallopian tube cancer
  • Brenner tumor
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



University of Minnesota Cancer CenterMinneapolis, Minnesota  55455