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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of topotecan when given weekly with cisplatin in patients with persistent, recurrent, or advanced stage cervical cancer. Secondary purposes are to describe the toxicity profile in patients with persistent, recurrent, or advanced stage cervical cancer treated with the combination of topotecan when given weekly with cisplatin and to determine the response rate and time to progression in patients with persistent, recurrent, or advanced stage cervical cancer treated with the combination of topotecan when given weekly with cisplatin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: GlaxoSmithKline
• Treatments: Cisplatin; Topotecan

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.