A Phase I Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer
18 Years
N/A
Female
Cervical Cancer
Trial Information
A Phase I Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer
OBJECTIVES:
- Determine the maximum tolerated dose of topotecan when administered with cisplatin in
patients with advanced cervical cancer.
- Identify any unique toxicities associated with administering radiotherapy along with
adjuvant cisplatin and topotecan in patients with cervical cancer.
- Determine the feasibility of administering continuous infusion topotecan chemotherapy
together with radiation therapy.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of topotecan.
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36.
Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously
(IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5,
8-12, 15-19, 22-26, 29-33, and 36. Treatment continues 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 preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Quality of life is assessed at baseline and at 4 and 14 weeks after completion of study
treatment.
After completion of study treatment, patients are followed periodically.
Inclusion Criteria:
- Histologically confirmed cervical carcinoma
- Deemed not curable by surgery or radiotherapy alone
- The following stages are eligible:
- Stage IIB
- Stage IIIA or IIIB
- Stage IVA
- Stage IB or IIA with ≥ 1 of the following risk factors:
- Primary tumor ≥ 6 cm
- Positive pelvic and/or para-aortic lymph nodes (resected or
unresected)
- Positive surgical margins
- Depth of invasion > 50% and positive capillary-lymphatic space
involvement
- The following histologic subtypes are eligible:
- Squamous
- Adenosquamous
- Adenocarcinoma
- No recurrent cervical cancer
- Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
- White blood cells (WBC) ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Granulocyte count ≥ 1,500/mm^3
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 1.5 times institutional normal
- Serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase ≤ 3 times
institutional normal
- No other prior or concurrent malignancies other than skin (excluding melanoma)
- No septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction
- No anatomic abnormalities (e.g., pelvic kidney or renal transplant) requiring
modification of radiation fields
- Fertile patients must use effective contraception
- Negative pregnancy test
- Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block,
heart block) are eligible if disease is stable for the past 6 months
- Recovered from recent surgery
Exclusion Criteria:
- Prior pelvic radiation
- Pregnant or nursing
- History of thrombus
- History of unstable angina or myocardial infarction within the past 6 months
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of topotecan
Outcome Description:
Adequate Response Trial Minimum length of trial to evaluate response is defined as receiving the first course of chemotherapy and living at least three weeks for repeat measurement to be performed.
Outcome Time Frame:
Week 3 After First Course of Therapy
Safety Issue:
Yes
Principal Investigator
Linda F. Carson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000452043
NCT ID:
NCT00287911
Start Date:
February 2005
Completion Date:
December 2009
Related Keywords:
- Cervical Cancer
- cervical adenocarcinoma
- cervical adenosquamous cell carcinoma
- 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 Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
