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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-9804 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when given with radiation therapy and cisplatin and to see how well they work in treating patients with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen.
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of paclitaxel.
Patients receive external beam radiotherapy (RT) to the para-aortic nodes and the pelvis daily for 5 weeks; RT must be completed within 8 weeks of its initiation. During or after external beam RT, intracavitary radiation is administered 1-5 times. Concurrently with external beam RT, patients receive paclitaxel IV over 1 hour followed immediately by cisplatin IV on days 1, 8, 15, 22, 29, and 36.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until the time of recurrence or death.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation therapy plus concurrent weekly chemotherapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug |
| ||
| paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment | up to 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival at 2 Years | Product-limit estimate of the probability of being alive and progression-free at 24 months based on those 20 patients who were treated at the study recommended dose level (RDL) is 0.65, 95% confidence interval (0.44-0.86). Progression is defined as a 50% or greater increase in the product from any lesion documented within eight weeks for study entry or the appearance of any new lesion within eight weeks of entry into study. |
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DISEASE CHARACTERISTICS:
Histologically proven previously untreated invasive carcinoma of the uterine cervix
TNM classification stage IIIB or IVA (FIGO classification stage IB, IIA, IIB, IIIA, IIIB, or IVA)
Cytologically or histologically proven metastases to the para-aortic lymph nodes
No more than 8 weeks since diagnosis
No metastases to scalene nodes, intraperitoneal metastases, or metastases to other organs outside the radiation field at the time of original clinical and surgical staging
Patients with ureteral obstruction must be treated with stent or nephrostomy tube
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Joan L. Walker, MD | Oklahoma University Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States | ||
| University of Chicago Cancer Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19010522 | Result | Walker JL, Morrison A, DiSilvestro P, von Gruenigen VE; Gynecologic Oncology Group. A phase I/II study of extended field radiation therapy with concomitant paclitaxel and cisplatin chemotherapy in patients with cervical carcinoma metastatic to the para-aortic lymph nodes: a Gynecologic Oncology Group study. Gynecol Oncol. 2009 Jan;112(1):78-84. doi: 10.1016/j.ygyno.2008.09.035. Epub 2008 Nov 17. |
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All patients received whole pelvic and extended field radiation at 150 centigray per day for 30 days to the para-aortics, and 180 centigray per day for 25 days to the pelvis.
In Period I 12 patients were treated with weekly cisplatin(30-40 mg/m2) and paclitaxel(30-50 mg/m2) concurrent with extended field radiation. In Period II an additional 17 patients were treated with cisplatin 40 mg/m2 and paclitaxel 40 mg/m2 concurrent with radiation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1, P I | Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2 |
| FG001 | Arm 2, P I | Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period I |
|
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| Drug |
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| brachytherapy | Radiation |
|
| radiation therapy | Radiation |
|
| 2 years |
| Overall Survival at 2 Years | Product-limit estimate of the probability of being alive at 24 months based on those 20 patients who were treated at the study recommended dose-level is 0.80, 95 % confidence interval (0.62-0.97) | 2 years |
| Chicago |
| Illinois |
| 60637-1470 |
| United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242 | United States |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden | New Jersey | 08103 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio | 43210 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214 | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Care Associates - Midtown Tulsa | Tulsa | Oklahoma | 74104 | United States |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| FG002 | Arm 3, P I | Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2 |
| FG003 | Arm 4, P I | Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2 |
| FG004 | Arm 2, P II | Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2 |
| COMPLETED |
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| NOT COMPLETED |
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| Period II |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1, P I | Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2 |
| BG001 | Arm 2, P I | Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2 |
| BG002 | Arm 2, P II | Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2 |
| BG003 | Arm 3, P I | Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2 |
| BG004 | Arm 4, P I | Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| FIGO (International Federation of Gynecology and Obstetrics) Stage | Clinical staging - Carcinoma of the Cervix Uteri FIGO Classification 1995 specifying invasive carcinoma from Stage 1A (confined to the cervix, identified only microscopically) to Stage 4B (spread to distant organs). | Number | participants |
| |||||||||||||||
| Cell Type | Number | participants |
|
| 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 | Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment | Posted | Number | participants | up to 21 weeks |
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| Secondary | Disease-free Survival at 2 Years | Product-limit estimate of the probability of being alive and progression-free at 24 months based on those 20 patients who were treated at the study recommended dose level (RDL) is 0.65, 95% confidence interval (0.44-0.86). Progression is defined as a 50% or greater increase in the product from any lesion documented within eight weeks for study entry or the appearance of any new lesion within eight weeks of entry into study. | Posted | Mean | 95% Confidence Interval | probability | 2 years |
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| Secondary | Overall Survival at 2 Years | Product-limit estimate of the probability of being alive at 24 months based on those 20 patients who were treated at the study recommended dose-level is 0.80, 95 % confidence interval (0.62-0.97) | Posted | Mean | 95% Confidence Interval | probability | 2 years |
|
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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 | Arm 1, P I | Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2 | 0 | 3 | 3 | 3 | ||
| EG001 | Arm 2, P I | Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2 | 0 | 3 | 3 | 3 | ||
| EG002 | Arm 3, P I | Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2 | 1 | 3 | 3 | 3 | ||
| EG003 | Arm 4, P I | Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2 | 2 | 3 | 2 | 3 | ||
| EG004 | Arm 2, P II | Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2 | 1 | 17 | 15 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary disorders | Cardiac disorders | CTCAE (2.0) |
| ||
| Nausea and vomiting | Gastrointestinal disorders | CTCAE (2.0) |
| ||
| Hypomagnesia | Metabolism and nutrition disorders | CTCAE (2.0) |
| ||
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) |
| ||
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) |
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| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) |
| ||
| Pulmonary Embolism | Cardiac disorders | CTCAE (2.0) |
| ||
| Hypotension | Cardiac disorders | CTCAE (2.0) |
| ||
| Fatigue | General disorders | CTCAE (2.0) |
| ||
| Nausea and vomiting | Gastrointestinal disorders | CTCAE (2.0) |
| ||
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) |
| ||
| Vaginal Bleeding | General disorders | CTCAE (2.0) | CTCAE 2.0 categorized as "Hemorrhage" |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (2.0) |
| ||
| Hypomagnesia | Metabolism and nutrition disorders | CTCAE (2.0) |
| ||
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) |
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| Weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) |
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| Seizure | Nervous system disorders | CTCAE (2.0) |
| ||
| Confusion | Nervous system disorders | CTCAE (2.0) |
| ||
| Pelvic pain | General disorders | CTCAE (2.0) | CTCAE 2.0 categorized as "Pain" |
| |
| Abdominal pain | General disorders | CTCAE (2.0) | CTCAE 2.0 categorized as "Pain" |
| |
| ALT | Hepatobiliary disorders | CTCAE (2.0) |
| ||
| Prothrombin time | Vascular disorders | CTCAE (2.0) | CTCAE 2.0 categorized as "Coagulation" |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Leventhal | Gynecologic Oncology Group Statistical & Data Center | (716)845-5702 | mleventhal@gogstats.org |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D001918 | Brachytherapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
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| 30-39 years |
|
| 40-49 years |
|
| 50-59 years |
|
| 60-69 years |
|
| Male |
|
| 1B - disease confined to cervix |
|
| 2A - no obvious parametrial involvement |
|
| 2B - obvious parametrial involvement |
|
| 3A -disease in lower 3rd of vagina not pelvic wall |
|
| 3B - disease extended to pelvic wall |
|
| 4A - disease spread to adjacent organs |
|
| 4B - disease spread to distant organs |
|
| Clear cell |
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| Squamous cell |
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| Complications unrelated to treatment |
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| Denominators |
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| Categories |
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