Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer

Tracking Information
First Submitted Date ICMJE	February 6, 2006
First Posted Date ICMJE	February 7, 2006
Last Update Posted Date	December 2, 2017
Study Start Date ICMJE	February 2005
Actual Primary Completion Date	December 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 9, 2010)	Maximum tolerated dose of topotecan [ Time Frame: Week 3 After First Course of Therapy ]; 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.
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00287911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer
Official Title ICMJE	A Phase I Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer
Brief Summary	RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Topotecan and cisplatin may make tumor cells more sensitive to radiation therapy. Giving topotecan and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cisplatin and radiation therapy in treating patients with advanced cervical cancer.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Cervical Cancer
Intervention ICMJE	Drug: cisplatin intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 Other Names: cisplatinum CDDP Platinol AQ; Drug: topotecan hydrochloride intravenously continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 -Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined Other Name: Hycamtin; Radiation: brachytherapy Some patients may also undergo brachytherapy; Radiation: radiation therapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 Other Name: radiation
Study Arms	Experimental: Combo Chemotherapy and Radiation; 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.; Interventions: Drug: cisplatin; Drug: topotecan hydrochloride; Radiation: brachytherapy; Radiation: radiation therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 9, 2010)	18
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	December 2009
Actual Primary Completion Date	December 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00287911
Other Study ID Numbers ICMJE	CDR0000452043; UMN-2001LS041 ( Other Identifier: CPRC, University of Minnesota ); UMN-WCC-34 ( Other Identifier: Women's Cancer Center, University of Minnesota ); 104864/638 ( Other Identifier: GlaxoSmithKline )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Masonic Cancer Center, University of Minnesota
Study Sponsor ICMJE	Masonic Cancer Center, University of Minnesota
Collaborators ICMJE	GlaxoSmithKline
Investigators ICMJE	Study Chair: Linda F. Carson, MD Masonic Cancer Center, University of Minnesota
PRS Account	Masonic Cancer Center, University of Minnesota
Verification Date	November 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP