Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

A Phase I Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00320983

Enrollment

Registered

2006-05-03

Start date

2002-03-31

Completion date

2005-12-31

Last updated

2010-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Cancer, Cervix

Brief summary

A Phase I Study of Adjuvant Topotecan and Cisplatin with Concurrent Radiation Therapy for Advanced Cervical Cancer.

Detailed description

Examines the effects of Topotecan and Cisplatin with radiation for advanced cervical cancer

Interventions

DRUGTopotecan

Topotecan

DRUGCisplatin

Cisplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Patients with histologically confirmed advanced cervical carcinoma who, following optional surgical staging, are not deemed to be curable by either surgery or radiotherapy alone. This includes patients with stages IIB, IIIA, IIIB or IVA and stages IB or IIA who in addition have one 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 greater than 50 % and positive capillary-lymphatic space involvement * Eligible cell types include squamous, adenosquamous and adenocarcinoma of the cervix * Patients may have measurable disease (defined as lesions which can be measured in at least two (2) dimensions by physical examination or any medical imaging technique). Inability to measure disease will not constitute

Exclusion criteria

. * Patients with GOG performance status of 0, 1, or 2. * Patients will have recovered from the effects of recent surgery and should be free of clinically significant infection. * Patients must have adequate: * Bone marrow function: WBC greater than or equal to 3,000 cells/mm3, platelet count greater than or equal to 100,000 cells/mm3, and granulocyte count greater than or equal to 1,500 cells/mm3. * Renal function: Creatinine less than or equal to 2.0 mg/dl. * Hepatic function: Bilirubin less than or equal to 1.5 x institutional normal, SGOT and alkaline phosphatase less than or equal to 3 x institutional normal. * Patients must have signed an approved informed consent. * Patients have met the pre-entry requirements specified in Section 7.0

Design outcomes

Primary

Measure	Time frame
disease progression	disease progress or complete remission

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026