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A Phase I Study of Extended Field Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes

Phase 1
18 Years
Not Enrolling
Cervical Cancer

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Trial Information

A Phase I Study of Extended Field Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes


- Determine the toxicity of extended field radiotherapy with concurrent paclitaxel and
cisplatin chemotherapy (as radiation sensitization) in patients with previously
untreated carcinoma of the cervix metastatic to the para-aortic lymph nodes.

- Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus
extended field radiotherapy in this patient population.

- Determine the effect of this treatment regimen on progression-free survival, overall
survival, and site of recurrence (local vs distant) in these patients.

OUTLINE: This is a multicenter, dose-escalation study of paclitaxel.

Patients receive external beam radiotherapy (RT) to the para-aortic nodes and the pelvis
daily for 5 weeks; RT must be completed within 8 weeks of its initiation. During or after
external beam RT, intracavitary radiation is administered 1-5 times. Concurrently with
external beam RT, patients receive paclitaxel IV over 1 hour followed immediately by
cisplatin IV on days 1, 8, 15, 22, 29, and 36.

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 at least 2
of 6 patients experience dose-limiting toxicity.

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

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4 years.

Inclusion Criteria


- Histologically proven previously untreated invasive carcinoma of the uterine cervix

- Squamous cell carcinoma

- Adenosquamous carcinoma

- Adenocarcinoma

- TNM classification stage IIIB or IVA (FIGO classification stage IB, IIA, IIB, IIIA,

- Cytologically or histologically proven metastases to the para-aortic lymph nodes

- No more than 8 weeks since diagnosis

- No metastases to scalene nodes, intraperitoneal metastases, or metastases to other
organs outside the radiation field at the time of original clinical and surgical

- Negative CT scan of the chest

- Patients with ureteral obstruction must be treated with stent or nephrostomy tube



- 18 and over

Performance status:

- GOG 0-2

Life expectancy:

- At least 6 months


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal


- Creatinine less than 2.0 mg/dL

- No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal
transplantation) requiring modification of radiation fields


- Not pregnant

- No septicemia or severe infection

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer


Biologic therapy:

- Not specified


- No prior cytotoxic chemotherapy for this or other malignancy

Endocrine therapy:

- Not specified


- No prior radiotherapy for this or other malignancy

- No prior radiotherapy to pelvis or abdomen


- Not specified


- No other prior therapy for this malignancy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment

Outcome Time Frame:

up to 21 weeks

Safety Issue:


Principal Investigator

Joan L. Walker, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute


United States: Federal Government

Study ID:




Start Date:

November 1999

Completion Date:

July 2009

Related Keywords:

  • Cervical Cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms



University of Chicago Cancer Research Center Chicago, Illinois  60637
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees Camden, New Jersey  08103