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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Joan L. Walker, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066374

NCT ID:

NCT00003379

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Cervical Cancer
  • 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
  • Uterine Cervical Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Cooper University HospitalCamden, New Jersey  08103
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Gynecologic Oncology NetworkNashville, Tennessee  37203