S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug or combining chemotherapy with surgery
      may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in
      treating patients who have stage III or stage IV ovarian epithelial cancer, primary
      peritoneal cancer, or fallopian tube cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the overall survival and progression-free survival in patients with stage III
           or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
           treated with neoadjuvant paclitaxel and carboplatin followed by surgery and adjuvant
           paclitaxel and carboplatin.

        -  Estimate the percentage of these patients whose disease is successfully cytoreduced to
           less than 1 cm in diameter following neoadjuvant chemotherapy.

        -  Evaluate the toxicity of this regimen in these patients.

        -  Explore the relationship between tumor p53 expression, proliferation rate as measured by
           proliferating cell nuclear antigen and apoptotic rate, and human tumor cloning assay
           results at time of debulking surgery with progression-free survival and overall survival
           in these patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive neoadjuvant therapy comprising paclitaxel IV over 3 hours followed by
      carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in
      the absence of disease progression or unacceptable toxicity. Within 35 days of receiving the
      third course of chemotherapy, patients with at least a 50% reduction in CA 125 undergo
      debulking surgery. Within 35 days of undergoing surgery, patients with a tumor reduction to
      below 1 cm receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by
      carboplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats
      every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
      annually for up to 5 years.

      PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 3 years.
    

Intervention name(s): carboplatin; paclitaxel; debulking surgery
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): pre-surgery - target AUC=6, Day 1 IV, q 21 days X 3 cycles post-surgery - target AUC=5, Day 1 IP, q 28 days X 6 cycles; pre-surgery - 175 mg/m2 IV Day 1, q 21 days X 3 cycles post-surgery - 175 mg/m2 IV Day 1, q 28 days X 6 cycles AND 60 mg/m2 IP Day 8, q 28 days X 6 cycles; exploratory laparotomy, interval cytoreduction (to < 1 cm residual)
Other intervention name(s): carbo; Taxol; surgery; debulking; cytoreduction; laparotomy
Intervention MeSH terms: Paclitaxel; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; ovarian undifferentiated adenocarcinoma; ovarian serous cystadenocarcinoma; ovarian mucinous cystadenocarcinoma; ovarian endometrioid adenocarcinoma; ovarian clear cell cystadenocarcinoma; fallopian tube cancer; peritoneal cavity cancer