Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy and Surgery in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
This study has been completed.
Study NCT00008138   Information provided by National Cancer Institute (NCI)
First Received: January 6, 2001   Last Updated: February 6, 2009   History of Changes

January 6, 2001
February 6, 2009
March 2001
November 2008   (final data collection date for primary outcome measure)
Overall survival [ Designated as safety issue: No ]
Overall survival
Complete list of historical versions of study NCT00008138 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy and Surgery in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer

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.

OBJECTIVES:

  • Determine 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.
  • Determine the percentage of these patients whose disease is successfully cytoreduced to less than 1 cm in diameter following neoadjuvant chemotherapy.
  • Determine the toxicity of this regimen in these patients.
  • Determine 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.

Phase II
Interventional
Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Drug: carboplatin
  • Drug: paclitaxel
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
 
Tiersten AD, Liu PY, Smith HO, Wilczynski SP, Robinson WR 3rd, Markman M, Alberts DS. Phase II evaluation of neoadjuvant chemotherapy and debulking followed by intraperitoneal chemotherapy in women with stage III and IV epithelial ovarian, fallopian tube or primary peritoneal cancer: Southwest Oncology Group Study S0009. Gynecol Oncol. 2009 Jan 10; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
November 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer

    • Adenocarcinoma
    • Large pelvic mass and/or bulky abdominal disease and/or malignant pleural effusion
    • Pleural effusion only for stage IV (parenchymal, liver, lung, or other distant metastases not allowed)
    • No borderline or low-malignant potential tumors
  • Optimal cytoreduction clinically deemed unlikely
  • CA 125 at least 70 units/mL

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT no greater than 2 times ULN

Renal:

  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • No congestive heart failure or cardiac arrhythmia
  • No myocardial infarction or angina within past 6 months

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding
  • No grade 2 or greater sensory neuropathy
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
  • No active or uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for this cancer

Chemotherapy:

  • No prior chemotherapy for this cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior pelvic radiation for this cancer

Surgery:

  • See Disease Characteristics
  • Prior exploratory laparotomy allowed provided an aggressive tumor debulking procedure was not performed (e.g., bilateral salpingo-oophorectomy/total abdominal hysterectomy with omentectomy)
  • Prior salpingo-oophorectomy and/or partial omentectomy allowed

Other:

  • No other concurrent anti-cancer therapy
Female
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00008138
 
CDR0000068380, SWOG-S0009
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Amy D. Tiersten, MD New York University School of Medicine
National Cancer Institute (NCI)
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP