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 currently recruiting participants.
Verified December 2011 by National Cancer Institute (NCI)
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01295502
First received: February 11, 2011
Last updated: December 7, 2011
Last verified: December 2011
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Purpose
RATIONALE: 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.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: carboplatin Drug: carboplatin-Taxol regimen Drug: cisplatin Drug: paclitaxel Procedure: adjuvant therapy Radiation: brachytherapy Radiation: external beam radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 National Cancer Institute (NCI):
Primary Outcome Measures:
- Maximum-tolerated dose (MTD) of adjuvant carboplatin and paclitaxel [ Designated as safety issue: Yes ]
- Dose-limiting toxicities (DLT) of adjuvant carboplatin and paclitaxel [ Designated as safety issue: Yes ]
- Toxicities as assessed by NCI CTCAE v. 4 [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response rate in patients enrolled with measurable disease [ Designated as safety issue: No ]
- Progression-free survival at one year and overall survival [ Designated as safety issue: No ]
- Location of recurrence (loco-regional versus distant) [ Designated as safety issue: No ]
- Chronic toxicities experienced within one year of study entry [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 45 |
| Study Start Date: | May 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- 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.
- To determine the feasibility of the treatment regimen over the four courses of adjuvant chemotherapy once the MTD is estimated.
- To assess the toxicities of the treatment regimen according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Secondary
- To assess the response rate to this treatment regimen in patients with measurable disease.
- To examine progression-free survival at one year on this treatment regimen.
- To examine overall survival.
- To estimate the frequency of chronic toxicities experienced within one year of study entry.
OUTLINE: This is a multicenter, dose-escalation study of carboplatin and paclitaxel.
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. 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
DISEASE CHARACTERISTICS:
Patients with histologically confirmed cervical cancer (squamous, adenocarcinoma, or adenosquamous)
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
- Scalene node sampling is NOT required
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine normal OR creatinine clearance > 50 mL/min
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Peripheral neuropathy (sensory and motor) ≤ grade 1
- 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
- No active infection
- No circumstances that will not permit completion of this study or the required follow-up
- No renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields
- Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
- No history of other invasive malignancies within the past 5 years except non-melanoma skin cancer
- No significant history of cardiac disease, (i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias) within the past 6 months
- No known sensitivity reactions to products containing Cremaphor® EL
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic or abdominal radiotherapy, cytotoxic chemotherapy, or therapy of any kind for this malignancy
- No prior cancer treatment that contraindicates this protocol therapy
- No major surgery, excluding diagnostic biopsy, within the past 30 days (to allow for full recovery)
- No other concurrent investigational agent
- No concurrent intensity-modulated radiotherapy or helical tomotherapy
- Patients may NOT receive amifostine or other protective reagents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295502
Locations
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242-1002 | |
| Contact: Cancer Information Service 800-237-1225 | |
| United States, Ohio | |
| Case Comprehensive Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44106-5065 | |
| Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Peter G. Rose, MD 216-444-1712 | |
| Riverside Methodist Hospital Cancer Care | Recruiting |
| Columbus, Ohio, United States, 43214-3998 | |
| Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I 401-274-1122 | |
| United States, Virginia | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298-0037 | |
| Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
| Principal Investigator: | Cecelia H. Boardman, MD | Massey Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01295502 History of Changes |
| Other Study ID Numbers: | CDR0000695304, GOG-9926 |
| Study First Received: | February 11, 2011 |
| Last Updated: | December 7, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
cervical adenocarcinoma cervical adenosquamous cell 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 |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Cisplatin Carboplatin |
Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013