Efficacy Study of Weekly Topotecan With Cisplatin in Advanced Stage or Recurrent Cervical Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00322920
• Date of registration: 05/05/2006
• Primary sponsor: University of Alabama at Birmingham
• Public title: Efficacy Study of Weekly Topotecan With Cisplatin in Advanced Stage or Recurrent Cervical Cancer
• Scientific title: A Phase I Study of Weekly Topotecan With Cisplatin for the Management of Advanced Stage or Recurrent Carcinoma of the Cervix
• Date of first enrolment: July 2005
• Target sample size: 30
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00322920
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: J. Michael Straughn, Jr., MD
• Affiliation: University of Alabama at Birmingham

Key inclusion & exclusion criteria

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
histology.

- 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.



Age minimum: 19 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cervix Cancer

Intervention(s)

Drug: Cisplatin

Drug: Topotecan

Primary Outcome(s)

MTD of topotecan when given weekly with cisplatin

Secondary Outcome(s)

Response rate and time to progression

Toxicity profile in patients treated with the combination of topotecan when given weekly with cisplatin

Secondary ID(s)

104799

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline