S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer

NCT ID: NCT00008138

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2009-11-30

Brief 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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemo/debulking surgery/IP chemo

neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

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

paclitaxel

Intervention Type: DRUG

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

debulking surgery

Intervention Type: PROCEDURE

exploratory laparotomy, interval cytoreduction (to \< 1 cm residual)

Interventions

carboplatin

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

Intervention Type: DRUG

paclitaxel

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

Intervention Type: DRUG

debulking surgery

exploratory laparotomy, interval cytoreduction (to \< 1 cm residual)

Intervention Type: PROCEDURE

Other Intervention Names

carbo; Taxol; surgery; debulking; cytoreduction; laparotomy

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy D. Tiersten, MD

Role: STUDY_CHAIR

NYU Langone Health

References

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 Mar;112(3):444-9. doi: 10.1016/j.ygyno.2008.10.028. Epub 2009 Jan 12.

Reference Type: RESULT

PMID: 19138791 (View on PubMed)

Other Identifiers

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S0009

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000068380

Identifier Type: -

Identifier Source: org_study_id