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

NCT00008138 | Completed Phase 2 Results

• 3 other identifiers: CDR0000068380U10CA032102S0009
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

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

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.

  assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5

• Progression-Free Survival

  Progression was defined as a CA-125 value that is both twice the nadir since registration and greater than 70 units/ml, and is confirmed by a second determination at least 7 days apart, or appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring removal from protocol treatment. Progression-Free Survival was defined as the time from the date of registration to the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.

  Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.

Study Arms (1)

chemo/debulking surgery/IP chemo

EXPERIMENTAL

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

Drug: carboplatin; Drug: paclitaxel; Procedure: debulking surgery

Interventions

carboplatin 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

Also known as: carbo

chemo/debulking surgery/IP chemo

paclitaxel 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

Also known as: Taxol

chemo/debulking surgery/IP chemo

debulking surgery PROCEDURE

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

Also known as: surgery, debulking, cytoreduction, laparotomy

chemo/debulking surgery/IP chemo

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• 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.

  PMID: 19138791 RESULT

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Paclitaxel; Cytoreduction Surgical Procedures; Surgical Procedures, Operative; Laparotomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: GYN Committee Statistician
• Organization: SWOG Statistical Center

206-667-4623

Study Officials

• Amy D. Tiersten, MD

  NYU Langone Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2001
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 8, 2016
• Results First Posted: August 24, 2012

Record last verified: 2015-12