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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA032102 | U.S. NIH Grant/Contract | View source | |
| S0009 | Other Identifier | SWOG |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemo/debulking surgery/IP chemo | Experimental | neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
Optimal cytoreduction clinically deemed unlikely
CA 125 at least 70 units/mL
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Amy D. Tiersten, MD | NYU Langone Health | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19138791 | Result | 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. |
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Of 62 enrolled participants, 4 were deemed ineligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Chemo/Debulking Surgery/IP Chemo | neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neoadjuvant Chemotherapy |
|
| |||||||||||||||||||||||||||
| Interval Debulking |
| ||||||||||||||||||||||||||||
| Post-Cytoreduction Chemotherapy |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Chemo/Debulking Surgery/IP Chemo | neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only eligible patients were included in the analysis. | Posted | Median | 95% Confidence Interval | months | assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5 |
|
Patients were assessed for adverse events every 3 weeks during neoadjuvant chemotherapy, and then every 4 weeks during intravenous/intraperitoneal chemotherapy following cytoreductive surgery.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 2.0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neoadjuvant Paclitaxel (IV) + Carboplatin (V) | Pre-surgery IV chemotherapy with paclitaxel and carboplatin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GYN Committee Statistician | SWOG Statistical Center | 206-667-4623 |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D065426 | Cytoreduction Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D007813 | Laparotomy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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|
| 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 |
|
|
| debulking surgery | Procedure | exploratory laparotomy, interval cytoreduction (to < 1 cm residual) |
|
|
| not protocol specified |
|
| NOT COMPLETED |
|
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Stage | Number | participants |
|
| Primary Site | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Only eligible patients were included in the analysis. | Posted | Oct 2011 | Median | 95% Confidence Interval | months | 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. |
|
|
|
| 1 |
| 58 |
| 41 |
| 58 |
| EG001 | Post-Cytoreduction Paclitaxel (IV/IP) + Carboplatin (IP) | post-surgery chemotherapy with IV and IP carboplatin and paclitaxel | 0 | 26 | 22 | 26 |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| PRBC transfusion | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Platelet transfusion | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Abdominal pain/cramping | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constipation/bowel obstruction | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhea without colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fatigue/malaise/lethargy | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fever without neutropenia | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pain-other | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Infection w/o 3-4 neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Respiratory infect w/o neutrop | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Urinary tr infect w/ neutrop | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Urinary tr infect w/o neutrop | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Catheter related infection | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
|
| Local injection site reaction | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
|
| Surgery-hemorrhage | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
|
| Leukopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Neutropenia/granulocytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| SGOT (AST) increase | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Thrombocytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Muscle weakness (not neuro) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dizziness/light headedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Weakness (motor neuropathy) | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anxiety/agitation | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Thrombosis/embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D005184 |
| Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |