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.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group Identifier:
First received: February 11, 2011
Last updated: December 23, 2014
Last verified: December 2014
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:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam RT
Radiation: Internal Radiation Therapy
Undergo brachytherapy
Other Names:
  • Brachytherapy
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Radiation Brachytherapy
Drug: Cisplatin
Given IV
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Carboplatin
Given IV

Detailed Description:


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.


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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT01295502

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
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Case Western Reserve University
Cleveland, Ohio, United States, 44106
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)
Principal Investigator: Cecelia Boardman Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group 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, Adenosquamous
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
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
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators processed this record on February 08, 2016