Cisplatin and Radiation Therapy Followed by Paclitaxel and Carboplatin in Treating Patients With Stage IB-IVA Cervical Cancer
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| ClinicalTrials.gov Identifier: NCT01295502 |
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Recruitment Status :
Active, not recruiting
First Posted : February 14, 2011
Last Update Posted : May 8, 2017
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Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Stage IB Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage IIIA Cervical Cancer Stage IIIB Cervical Cancer Stage IVA Cervical Cancer | Drug: Carboplatin Drug: Cisplatin Radiation: External Beam Radiation Therapy Radiation: Internal Radiation Therapy Drug: Paclitaxel | Phase 1 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 45 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 Start Date : | April 2011 |
| Estimated Primary Completion Date : | December 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Carboplatin
Given IV
Other Names:
Drug: Cisplatin Given IV
Other Names:
Radiation: External Beam Radiation Therapy Undergo EBRT
Other Names:
Radiation: Internal Radiation Therapy Undergo brachytherapy
Other Names:
Drug: Paclitaxel Given IV
Other Names:
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Primary Outcome Measures :
- MTD of adjuvant carboplatin and paclitaxel determined based on the dose-limiting toxicities assessed by NCI CTCAE version 4 [ Time Frame: 21 days ]
Secondary Outcome Measures :
- Chronic toxicities experienced classified using the CTCAE version 4 [ Time Frame: Within 1 year of study entry ]
- 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 ]
- Objective tumor response rate in patients enrolled with measurable disease [ Time Frame: Up to 1 year ]Will be tabulated overall.
- Overall survival [ Time Frame: Time from study entry to time of death or the date of last contact, assessed up to 1 year ]Survival will be summarized using Kaplan-Meier plots.
- Progression-free survival (PFS) [ Time Frame: Time from study entry to time of progression or death, whichever occurs first, assessed at 1 year ]PFS will be summarized using Kaplan-Meier plots.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295502
Locations
| United States, California | |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| United States, Connecticut | |
| Hartford Hospital | |
| Hartford, Connecticut, United States, 06102 | |
| The Hospital of Central Connecticut | |
| New Britain, Connecticut, United States, 06050 | |
| United States, Georgia | |
| Augusta University Medical Center | |
| Augusta, Georgia, United States, 30912 | |
| United States, Iowa | |
| University of Iowa/Holden Comprehensive Cancer Center | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Ohio | |
| Summa Akron City Hospital/Cooper Cancer Center | |
| Akron, Ohio, United States, 44304 | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Riverside Methodist Hospital | |
| Columbus, Ohio, United States, 43214 | |
| Hillcrest Hospital Cancer Center | |
| Mayfield Heights, Ohio, United States, 44124 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Rhode Island | |
| Women and Infants Hospital | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Virginia | |
| Virginia Commonwealth University/Massey Cancer Center | |
| Richmond, Virginia, United States, 23298 | |
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Cecelia Boardman | NRG Oncology |
| Responsible Party: | Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01295502 History of Changes |
| Other Study ID Numbers: |
GOG-9926 NCI-2011-02665 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000695304 GOG-9926 ( Other Identifier: NRG Oncology ) GOG-9926 ( Other Identifier: CTEP ) U10CA180868 ( U.S. NIH Grant/Contract ) U10CA027469 ( U.S. NIH Grant/Contract ) |
| First Posted: | February 14, 2011 Key Record Dates |
| Last Update Posted: | May 8, 2017 |
| Last Verified: | May 2017 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Adenocarcinoma Uterine Cervical Neoplasms Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Paclitaxel Albumin-Bound Paclitaxel Cisplatin Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |