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A Phase I Study Of Pelvic Radiation Therapy With Concomitant Cisplatin And Weekly Topotecan (IND# 58,13) Chemotherapy In Patients With Cervical Carcinoma And Paraortic Nodal Metastasis As The Only Evidence Of Extrapelvic Disease


Phase 1
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Phase I Study Of Pelvic Radiation Therapy With Concomitant Cisplatin And Weekly Topotecan (IND# 58,13) Chemotherapy In Patients With Cervical Carcinoma And Paraortic Nodal Metastasis As The Only Evidence Of Extrapelvic Disease


OBJECTIVES:

Primary

- Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan
in patients with locally advanced cervical cancer.

- Determine the maximum tolerated dose (MTD) of topotecan when administered in this
regimen in this patient population.

Secondary

- Determine the site of recurrence (local vs distant) in patients treated with this
regimen.

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

Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and
topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease
progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients
experiences dose-limiting toxicity. Once the MTD is determined, an additional cohort of 20
patients receives treatment as above at the MTD.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary invasive carcinoma of the uterine cervix

- Stages IB2, II, IIIB, and IVA disease

- Any cell type

- No known metastasis to scalene nodes or organs outside the radiation field

- No known intraperitoneal metastases

- No evidence of extrapelvic disease based on negative CT or PET scan

- Must enroll within 8 weeks of diagnosis

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- GOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

Renal

- Creatinine normal OR

- Creatinine clearance > 50 mL/min

- Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed

- No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal
transplantation that would require modification of radiation fields

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except nonmelanoma skin cancer

- No septicemia or severe infection

- No other medical or psychiatric condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for any prior malignancy

- No prior cytotoxic chemotherapy for this malignancy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for any prior malignancy

- No prior pelvic or abdominal radiotherapy for this malignancy

Surgery

- See Patient Characteristics- Renal

Other

- No prior therapy for this malignancy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter G. Rose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000270680

NCT ID:

NCT00054444

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Cervical Cancer
  • cervical adenocarcinoma
  • cervical squamous cell carcinoma
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • stage IIB cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • Uterine Cervical Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240