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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

cisplatin

topotecan hydrochloride

brachytherapy

radiation therapy

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Minnesota Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combo Chemotherapy and Radiation

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose of topotecan

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00287911

First Posted

February 6, 2006

Last Updated

November 29, 2017

Sponsor

Masonic Cancer Center, University of Minnesota

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00287911

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Masonic Cancer Center, University of Minnesota

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combo Chemotherapy and Radiation

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

cisplatin

Other Intervention Name(s)

cisplatinum, CDDP, Platinol AQ

Intervention Description

intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36

Intervention Type

Drug

Intervention Name(s)

topotecan hydrochloride

Other Intervention Name(s)

Hycamtin

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

brachytherapy

Intervention Description

Some patients may also undergo brachytherapy

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Other Intervention Name(s)

radiation

Intervention Description

once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36

Primary Outcome Measure Information:

Title

Maximum tolerated dose of topotecan

Description

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.

Time Frame

Week 3 After First Course of Therapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda F. Carson, MD

Organizational Affiliation

Masonic Cancer Center, University of Minnesota

Official's Role

Study Chair

Facility Information:

Facility Name

University of Minnesota Cancer Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Cervical Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial