Clinical trial NCT00003379: Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer
Official title: A Phase I/II Study Of Whole Pelvic Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervical Cancer
Keywords: stage III cervical cancer
stage IB cervical cancer
stage IIB cervical cancer
stage IIA cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical small cell carcinoma
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy to the pelvis plus paclitaxel and cisplatin in treating patients who have cervical cancer.

Detailed description: OBJECTIVES:

* Determine the toxicity of radiotherapy plus paclitaxel and cisplatin used as radiosensitization in patients with stage IB2, IIA, IIB, IIIB, or IVA invasive carcinoma of the cervix.
* Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus radiotherapy in these patients.
* Determine the effects of this regimen at the maximum tolerated dose on progression-free survival and overall survival in these patients.
* Determine the site of local or distant recurrence in these patients after treatment with this regimen.

OUTLINE: This is a dose escalation study of paclitaxel.

Patients undergo external beam radiotherapy (RT) to the pelvic region 5 days a week during weeks 1-5. Patients receive paclitaxel IV over 1 hour immediately followed by cisplatin concurrently with pelvic field radiotherapy on days 1, 8, 15, 22, 29, and 36. Patients undergo low-dose rate (LDR) OR high-dose rate (HDR) brachytherapy. For patients undergoing LDR brachytherapy, intracavitary implants are inserted 1 or 2 times within 3 weeks after completion of external beam RT. For patients undergoing HDR brachytherapy, intracavitary implants are inserted once a week for 5 weeks beginning during week 4 of external beam RT. Patients may receive a parametrial boost.

Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the MTD as above.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or at time of recurrence until death.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3-7 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically proven stage IB2, IIA, IIB, IIIB, or IVA invasive carcinoma of the uterine cervix

  * Any cell type
* No metastases to para-aortic lymph nodes, scalene nodes, or to other organs outside the radiation field at time of original staging
* Study entry required within 8 weeks of diagnosis

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* GOG 0-2

Life expectancy:

* More than 6 months

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal

Renal:

* Creatinine less than 2.0 mg/dL
* No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiation fields

Other:

* Not pregnant
* No septicemia or severe infection
* No other invasive malignancy within the past 3 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior biologic therapy

Chemotherapy:

* No prior chemotherapy for this or any prior malignancy

Endocrine therapy:

* No prior endocrine therapy

Radiotherapy:

* No prior pelvic or abdominal radiotherapy for this malignancy
* No prior radiotherapy for any other prior malignancy
* No more than 1 month interval between surgery and radiotherapy

Surgery:

* See Radiotherapy

Other:

* No other prior therapy for this malignancy
* Stent or nephrostomy tube required if ureteral obstruction present

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: CCOP - Western Regional, Arizona
state: Arizona
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Chicago
country: United States
facility: MBCCOP - University of Illinois at Chicago
state: Illinois
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Evanston
country: United States
facility: CCOP - Evanston
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: South Bend
country: United States
facility: Saint Joseph Regional Medical Center
state: Indiana
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: Springfield
country: United States
facility: CCOP - Cancer Research for the Ozarks
state: Missouri
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Medicine
state: Oklahoma
city: Portland
country: United States
facility: CCOP - Columbia River Oncology Program
state: Oregon
city: Danville
country: United States
facility: CCOP - Geisinger Clinic and Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center at Magee-Womens Hospital
state: Pennsylvania
city: Knoxville
country: United States
facility: Southeast Gynecologic Oncology Associates
state: Tennessee
city: Nashville
country: United States
facility: Gynecologic Oncology Network
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
state: Tennessee
city: Temple
country: United States
facility: CCOP - Scott and White Hospital
state: Texas
Study officials:
affiliation: Oklahoma University Cancer Institute
name: Joan L. Walker, MD
role: STUDY_CHAIR
affiliation: Stony Brook University
name: Michael L. Pearl, MD
affiliation: Women's Cancer Center - Los Gatos
name: Ming-teh D. Chen, MD
References:
citation: DiSilvestro PA, Walker JL, Morrison A, Rose PG, Homesley H, Warshal D; Gynecologic Oncology Group. Radiation therapy with concomitant paclitaxel and cisplatin chemotherapy in cervical carcinoma limited to the pelvis: a phase I/II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Dec;103(3):1038-42. doi: 10.1016/j.ygyno.2006.06.017. Epub 2006 Aug 4.
citation: Walker J, Morrison A, DiSilvestro P, et al.: GOG protocol 9803: phase I evaluation of the treatment of invasive cervical cancer confined to the pelvis with combination of radiation and weekly cisplatin and paclitaxel. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-157, 46, 2004.