Cisplatin and Radiation Therapy Followed by Paclitaxel and Carboplatin in Treating Patients With Stage IB-IVA Cervical Cancer
A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cervical Carcinoma Metastatic to the Para-aortic Lymph Nodes
5 other identifiers
interventional
45
1 country
14
Brief Summary
This phase I trial studies the side effects and the best dose of paclitaxel and carboplatin after cisplatin and radiation therapy in treating patients with stage IB-IVA cervical cancer. Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel and carboplatin after cisplatin and radiation therapy may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedStudy Start
First participant enrolled
April 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2019
CompletedMarch 12, 2019
March 1, 2019
8.7 years
February 11, 2011
March 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
MTD of adjuvant carboplatin and paclitaxel determined based on the dose-limiting toxicities assessed by NCI CTCAE version 4
21 days
Secondary Outcomes (5)
Objective tumor response rate in patients enrolled with measurable disease
Up to 1 year
Progression-free survival (PFS)
Time from study entry to time of progression or death, whichever occurs first, assessed at 1 year
Overall survival
Time from study entry to time of death or the date of last contact, assessed up to 1 year
Location of recurrence (loco-regional versus distant) defined as newly evident disease for patients who have no evidence of disease at baseline or progressive disease for patients who have strictly non-measurable disease at baseline
Up to 1 year
Chronic toxicities experienced classified using the CTCAE version 4
Within 1 year of study entry
Study Arms (1)
Treatment (radiation, cisplatin, paclitaxel, carboplatin)
EXPERIMENTALPatients receive cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and undergo extended-field radiotherapy daily 5 days a week for 6 weeks followed by brachytherapy. Beginning 4-6 weeks after completion of chemoradiation, patients receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Undergo EBRT
Undergo brachytherapy
Given IV
Eligibility Criteria
You may qualify if:
- Patients with histologically confirmed cervical cancer (squamous, adenocarcinoma, or adenosquamous): International Federation of Gynecology and Obstetrics (FIGO) clinical stages IB, IIA, IIB, IIIA, IIIB, IVA, with positive para-aortic lymph nodes confirmed by positron emission tomography (PET)/computed tomography (CT) scan, fine needle biopsy, extraperitoneal biopsy, laparoscopic biopsy or lymphadenectomy
- Patients must have a Gynecologic Oncology Group (GOG) performance status of 0-2
- Absolute neutrophil count (ANC) \>= 1,500/mcl
- Platelets \>= 100,000/mcl
- Creatinine =\< institutional upper limit normal (ULN); Note: if creatinine \> ULN, creatinine clearance must be \> 50 mL/min
- Bilirubin =\< 1.5 times ULN
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN
- Alkaline phosphatase =\< 2.5 x ULN
- Neuropathy (sensory and motor) =\< grade 1
- Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
- Patients must meet the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting the release of personal health information
- Patients of child-bearing potential must have a negative serum pregnancy test prior to study entry (within 72 hours prior to initiation of study treatment) and be practicing an effective form of contraception; women should not breast-feed while on this study
- Patients must not be receiving any other investigational agent
- Patients should have an audiogram at baseline, and patients with pre-existing hearing loss or hearing loss during treatment should be assessed frequently during cisplatin therapy
You may not qualify if:
- Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy
- Patients with active infection
- Patients who have circumstances that will not permit completion of this study or the required follow-up
- Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have undergone major surgery, excluding diagnostic biopsy, within 30 days (to allow for full recovery) prior to registration
- Patients who have a significant history of cardiac disease, (i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias) within 6 months of registration
- Patients who have a known sensitivity reactions to products containing Cremophor EL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (14)
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cecelia H Boardman
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2011
First Posted
February 14, 2011
Study Start
April 4, 2011
Primary Completion
December 2, 2019
Last Updated
March 12, 2019
Record last verified: 2019-03