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A Phase I Study of Weekly Topotecan With Cisplatin for the Management of Advanced Stage or Recurrent Carcinoma of the Cervix

Phase 1
19 Years
Not Enrolling
Cervix Cancer

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Trial Information

A Phase I Study of Weekly Topotecan With Cisplatin for the Management of Advanced Stage or Recurrent Carcinoma of the Cervix

Patients diagnosed with recurrent cervical cancer generally have limited options for cure.
Occasionally, radiation therapy may be utilized in localized recurrent disease with curative
intent; however, most patients are not candidates for curative therapy secondary to
disseminated disease, and thus are frequently treated with palliative chemotherapy. Initial
experiences with chemotherapy in this clinical setting demonstrated cisplatin to be an
active agent. Subsequent trials using combinations of cisplatin and ifosfamide or
paclitaxel demonstrated higher response rates compared to cisplatin alone but did not
demonstrate an improvement in overall survival. Topotecan is a topoisomerase I inhibitor
that has been used in the management of cervical and ovarian cancer. Several phase II
studies have demonstrated topotecan to be an active agent in cervical cancer. In an effort
to ameliorate toxicity noted with 3-5 day dosing regimens of topotecan, investigators have
evaluated weekly dosing of topotecan. Thus far, the toxicity of weekly topotecan dosing in
cervical cancer has not been evaluated. In this study, topotecan will be given weekly at
escalating dose levels starting at 2.0 mb/m2 with standard cisplatin at 50 mg/m2 every 21
days. This study will help to determine acceptable dosing for the combination of weekly
topotecan and cisplatin in patients with persistent, recurrent, or advanced stage cervical
cancer which can then be utilized in a cohort of patients with cervical cancer in a phase II

Inclusion Criteria:

- Patients must have persistent, recurrent, or primary Stage IVB carcinoma of the
cervix not amenable to curative therapy with either surgery and/or radiation.

- Patients must have biopsy proven squamous cell, adenosquamous, or adenocarcinoma

- Patients do not require measurable disease.

- Patients must have adequate organ function defined by laboratory work.

- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of
0 or 1.

- Patients must have recovered from any effects attributable to surgery, radiation, or
chemoradiotherapy. A minimum of six weeks shall have passed since the last
administration of chemoradiotherapy or three weeks for radiation therapy alone.

- Patients must be free of clinically significant infections.

- Patients must be age 19 or greater and have signed informed consent.

Exclusion Criteria:

- Patients who are pregnant or lactating.

- Patients with history of other malignancies (except non-melanoma skin cancer) within
the last 5 years are ineligible.

- Patients with non-squamous, adenosquamous, or adenocarcinoma histology.

- Patients with bilateral hydronephrosis that cannot be alleviated by ureteral stents
or percutaneous drainage.

- Patients currently receiving any or having received other investigational agents
within the last 30 days are ineligible.

- Patients with known hypersensitivity to topotecan or cisplatin.

- Patients with craniospinal metastases.

- Patients with uncontrolled current illness including, but not limited to, ongoing or
active infection, unstable angina pectoris, cardiac arrhythmia, serious peripheral
neuropathy, or psychiatric illness/social situations that would limit or preclude
compliance with study requirements are ineligible.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD of topotecan when given weekly with cisplatin

Principal Investigator

J. Michael Straughn, Jr., MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Cervix Cancer
  • cervical cancer
  • topotecan
  • Stage IVB cervical cancer
  • Persistent or recurrent cervical cancer
  • Uterine Cervical Neoplasms



University of Alabama at BirminghamBirmingham, Alabama  35294-3300