Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase I Trial of Tailored Radiation Therapy With Concomitant Cetuximab (C225, NSC #714692) and Cisplatin (NSC #119875) in the Treatment of Patients With Cervical Cancer
Verified date | December 2014 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This phase I trial is studying the side effects and best dose of cetuximab when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving cetuximab together with cisplatin and radiation therapy may kill more tumor cells.
Status | Completed |
Enrollment | 64 |
Est. completion date | |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed cervical cancer - Clinical stage IB-IVA disease - Any cell type allowed - Positive or negative pelvic and/or para-aortic lymph nodes by radiography - Unstained sections from primary tumor available - Performance status - GOG 0-1 - Absolute neutrophil count = 1,500/mm^3 - Platelet count = 100,000/mm^3 - Bilirubin = 1.5 times upper limit of normal (ULN) - SGOT = 2.5 times ULN - Alkaline phosphatase = 2.5 times ULN - Creatinine normal - Creatinine clearance > 50 mL/min - Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry - No renal abnormality (e.g., pelvic kidney or horseshoe kidney) that would require modification of radiation fields - No significant cardiac disease within the past 6 months, including any of the following: - Uncontrolled hypertension - Unstable angina - Congestive heart failure - Uncontrolled arrhythmia - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No sensory or motor neuropathy > grade 1 - No septicemia - No severe infection - No circumstance that would preclude study participation or follow-up - No other invasive malignancy within the past 5 years except nonmelanoma skin cancer - No uncontrolled seizure disorder - No active neurologic disease - No history of active collagen vascular disease - No prior chimerized or murine monoclonal antibody therapy - No prior cytotoxic chemotherapy for cervical cancer - No prior pelvic or abdominal radiotherapy for cervical cancer - No concurrent intensity modulated radiotherapy - No prior renal transplantation - More than 30 days since prior major surgery (excluding diagnostic biopsy) - No other prior therapy for cervical cancer - No prior cancer treatment that would preclude study therapy - No other concurrent investigational agents |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Georgia Regents University Medical Center | Augusta | Georgia |
United States | Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Parkland Memorial Hospital | Dallas | Texas |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Lake University Ireland Cancer Center | Mentor | Ohio |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Women and Infants Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose (MTD) or biologically effective dose (BED) of Cetuximab in combination with cisplatin and extended field radiation or whole pelvis radiation, graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) | Evaluation of the regimens will be conducted separately by the type of radiation received (extended field radiation or whole pelvis radiation). | 6 weeks | Yes |
Primary | Incidence of toxicities at the MTD, assessed by CTCAE v3.0 | Up to 1 year | Yes | |
Secondary | Progression-free survival | From study entry until disease progression, death or date of last contact, up to 1 year | No | |
Secondary | Site of recurrence, loco-regional vs distant, assessed by clinical and radiological evaluation | From study entry until disease progression, death or date of last contact, up to 1 year | No | |
Secondary | Frequency of chronic toxicities, assessed by CTCAE v3.0 | From study entry until disease progression, death or date of last contact, up to 1 year | Yes |
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