- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295502
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
Study Overview
Status
Conditions
- Cervical Adenocarcinoma
- Cervical Adenosquamous Carcinoma
- Cervical Squamous Cell Carcinoma, Not Otherwise Specified
- Stage IIA Cervical Cancer AJCC v7
- Stage IIB Cervical Cancer AJCC v6 and v7
- Stage IIIB Cervical Cancer AJCC v6 and v7
- Stage IVA Cervical Cancer AJCC v6 and v7
- Stage IIIA Cervical Cancer AJCC v6 and v7
- Stage IB Cervical Cancer AJCC v6 and v7
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of adjuvant carboplatin and paclitaxel chemotherapy following concurrent weekly cisplatin chemotherapy and extended field radiation in women with newly diagnosed stage IB-IVA cervical cancer, with positive para-aortic nodes.
II. To determine the feasibility of the treatment regimen over the four cycles of adjuvant chemotherapy once the MTD is estimated.
III. To assess the toxicities of the treatment regimen the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
SECONDARY OBJECTIVES:
I. To assess the response rate to this treatment regimen in patients with measurable disease.
II. To examine progression-free survival for one year on this treatment regimen.
III. To examine overall survival. IV. To examine the location of recurrence, loco-regional versus distant for one year after completion of therapy.
V. To estimate the frequency of chronic toxicities experienced within one year of study entry.
OUTLINE: This is a dose-escalation study of carboplatin and paclitaxel.
Patients receive cisplatin intravenously (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.
After completion of study therapy, patients are followed up every 3 months for 1 year.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Orange, California, United States, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Connecticut
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Hartford, Connecticut, United States, 06102
- Hartford Hospital
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New Britain, Connecticut, United States, 06050
- The Hospital of Central Connecticut
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Georgia
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Augusta, Georgia, United States, 30912
- Augusta University Medical Center
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Ohio
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Akron, Ohio, United States, 44304
- Summa Akron City Hospital/Cooper Cancer Center
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University
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Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
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Mayfield Heights, Ohio, United States, 44124
- Hillcrest Hospital Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Women and Infants Hospital
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (radiation, cisplatin, paclitaxel, carboplatin)
Patients 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.
|
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo EBRT
Other Names:
Undergo brachytherapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MTD of adjuvant carboplatin and paclitaxel determined based on the dose-limiting toxicities assessed by NCI CTCAE version 4
Time Frame: 21 days
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21 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective tumor response rate in patients enrolled with measurable disease
Time Frame: Up to 1 year
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Will be tabulated overall.
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Up to 1 year
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Progression-free survival (PFS)
Time Frame: Time from study entry to time of progression or death, whichever occurs first, assessed at 1 year
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PFS will be summarized using Kaplan-Meier plots.
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Time from study entry to time of progression or death, whichever occurs first, assessed at 1 year
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Overall survival
Time Frame: Time from study entry to time of death or the date of last contact, assessed up to 1 year
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Survival will be summarized using Kaplan-Meier plots.
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Time from study entry to time of death or the date of last contact, assessed up to 1 year
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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
Time Frame: Up to 1 year
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Up to 1 year
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Chronic toxicities experienced classified using the CTCAE version 4
Time Frame: Within 1 year of study entry
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Within 1 year of study entry
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cecelia H Boardman, NRG Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Neoplasms, Complex and Mixed
- Neoplasms, Squamous Cell
- Uterine Cervical Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Carcinoma, Adenosquamous
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Cisplatin
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- GOG-9926 (Other Identifier: CTEP)
- U10CA180868 (U.S. NIH Grant/Contract)
- U10CA027469 (U.S. NIH Grant/Contract)
- NCI-2011-02665 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000695304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Catalysis SLCompletedCervical Carcinoma Stage II | Cervical Carcinoma Stage III | Cervical Carcinoma Stage IV | Endometrial Adenocarcinoma Stage II | Endometrial Adenocarcinoma Stage III | Endometrial Adenocarcinoma Stage IVCuba
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Merck Sharp & Dohme LLCCompletedPrevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in SituChina
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