Cisplatin and Radiation Therapy Followed by Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01295502
First received: February 11, 2011
Last updated: December 23, 2014
Last verified: December 2014
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Purpose
This phase I trial is studying cisplatin and radiation therapy followed by paclitaxel and carboplatin in treating patients with stage I, stage II, stage III, or stage IV 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 or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel and carboplatin (combination chemotherapy) after cisplatin and radiation therapy may kill more tumor cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Stage IB Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage III Cervical Cancer Stage IVA Cervical Cancer |
Radiation: External Beam Radiation Therapy Radiation: Internal Radiation Therapy Drug: Cisplatin Drug: Paclitaxel Drug: Carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Gynecologic Oncology Group:
Primary Outcome Measures:
- Maximum-tolerated dose (MTD) of adjuvant carboplatin and paclitaxel determined by dose-limiting toxicities assessed by NCI CTCAE v. 4 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Objective tumor response rate in patients enrolled with measurable disease [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Will be tabulated overall.
- Progression-free survival [ Time Frame: Time from study entry to time of progression or death, assessed at 1 year ] [ Designated as safety issue: No ]Will be summarized using Kaplan-Meier plots.
- Overall survival [ Time Frame: Time from study entry to time of death or the date of last contact, assessed up to 1 year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Chronic toxicities experienced classified using the CTCAE Version 4 [ Time Frame: Within 1 year of study entry ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 45 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | December 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (radiation, cisplatin, paclitaxel, carboplatin)
Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 and undergo extended-field radiotherapy (including brachytherapy) once daily, 5 days a week, for 6 weeks. 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.
|
Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
Radiation: Internal Radiation Therapy
Undergo brachytherapy
Other Names:
Drug: Cisplatin
Given IV
Drug: Paclitaxel
Given IV
Other Names:
Drug: Carboplatin
Given IV
|
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 courses of adjuvant chemotherapy once the MTD is estimated.
III. To assess the toxicities of the treatment regimen according to the 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 at 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) on days 1, 8, 15, 22, 29, and 36 and undergo extended-field radiotherapy (including brachytherapy) once daily, 5 days a week, for 6 weeks. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with histologically confirmed cervical cancer (squamous, adenocarcinoma, or adenosquamous): Féderation Internationale de Gynécologie et d'Obstétrique (FIGO) Clinical stages IB, IIA, IIB, IIIA, IIIB, IVA, with positive para-aortic lymph nodes confirmed by PET/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 glutamic pyruvic 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 Cremaphor EL
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295502
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295502
Locations
| United States, California | |
| University of California Medical Center At Irvine-Orange Campus | |
| 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 | |
| Georgia Regents University Medical Center | |
| Augusta, Georgia, United States, 30912 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| 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 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| 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
Investigators
| Principal Investigator: | Cecelia Boardman | Gynecologic Oncology Group |
More Information
No publications provided
| Responsible Party: | Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01295502 History of Changes |
| Other Study ID Numbers: | GOG-9926, NCI-2011-02665, CDR0000695304, GOG-9926, GOG-9926, U10CA027469 |
| Study First Received: | February 11, 2011 |
| Last Updated: | December 23, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Adenosquamous Carcinoma, Squamous Cell Uterine Cervical Neoplasms Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Urogenital Neoplasms Uterine Cervical Diseases |
Uterine Diseases Uterine Neoplasms Carboplatin Cisplatin Paclitaxel Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Phytogenic Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators |
ClinicalTrials.gov processed this record on March 02, 2015