S0009 Combination Chemotherapy and Surgery in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00008138

Purpose

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.

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: carboplatin Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Study Start Date:	March 2001
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008138

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Amy D. Tiersten, MD

New York University School of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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]

Responsible Party:	Laurence H. Baker, D.O., Chairman, SWOG
ClinicalTrials.gov Identifier:	NCT00008138 History of Changes
Other Study ID Numbers:	CDR0000068380, U10CA032102, SWOG-S0009
Study First Received:	January 6, 2001
Last Updated:	July 19, 2011
Health Authority:	United States: Federal Government

Keywords provided by Southwest Oncology Group:

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

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms

Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012