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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
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

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


OBJECTIVES:

- 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


DISEASE CHARACTERISTICS:

- 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,
IIIB, or IVA)

- 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
staging

- Negative CT scan of the chest

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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- GOG 0-2

Life expectancy:

- At least 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) requiring modification of radiation fields

Other:

- Not pregnant

- No septicemia or severe infection

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior cytotoxic chemotherapy for this or other malignancy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy for this or other malignancy

- No prior radiotherapy to pelvis or abdomen

Surgery:

- Not specified

Other:

- No other prior therapy for this malignancy

Type of Study:

Interventional

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:

Yes

Principal Investigator

Joan L. Walker, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066371

NCT ID:

NCT00003377

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Cancer Institute of New Jersey at the Cooper University Hospital - VoorheesCamden, New Jersey  08103