Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer

NCT00267488 | Completed Phase 2 Results

• 1 other identifier: 100414
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 24

Brief Summary

The purpose of this study is to find out if Hycamtin given weekly is safe and effective for treating your endometrial cancer.

Conditions

Neoplasms, Endometrial; Endometrial Cancer

Keywords

Hycamtin; endometrial cancer; topotecan

Outcome Measures

Primary Outcomes (1)

• Best Overall Response

  Tumor response based on GOG (Gynecological Oncology Group) modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. A 4-point scale used specifying tumor response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions; (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; (PD): At least a 20% increase in the sum of the LD of target lesions

  Week 0 to Week 98 when endpoints were met

Secondary Outcomes (5)

• Time to Progression

  Week 0 to Week 19 when endpoints were met

• Overall Survival

  Week 0 to Week 98

• Response Duration

  Week 0 to week 98

• Time to Response

  Week 0 to week 98

• Safety and Tolerability as Summarized Through Adverse Event Reporting

  Week 0 to week 98

Interventions

topotecan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided a written informed consent.
• Subject must be female and ≥18 years of age.
• Subjects' original endometrial carcinoma (any histologic type) must have had pathologic confirmation.
• Subject must have recurrent or persistent endometrial cancer.
• Subject must have at least one measurable lesion according to GOG-modified RECIST criteria.
• Measurable disease must be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation, plain X-ray, CT and MRI, or ≥10 mm when measured by spiral CT.
• Measurable disease found on chest X-ray must be confirmed with CT or MRI. Either CT or MRI must be used throughout the study to further evaluate these lesions.
• The same diagnostic method (CT, MRI, X-ray or physical exam) used to evaluate disease, must be used throughout the study to consistently evaluate lesions.
• Palpable tumor masses that cannot be evaluated by CT or MRI scan should be evaluated by ultrasound or confirmed by biopsy.
• Evaluable disease (measurable or non-measurable) may be in a field of prior radiation provided that at least six weeks have elapsed since receiving radiation and disease progression is clearly documented by radiographic study. It is preferential for the target lesion to be located outside an irradiated field.
• Non-measurable disease is defined as all other lesions, including small lesions (longest diameter \<20 mm with conventional techniques or \<10 mm with spiral CT scan).
• Subject has received one prior chemotherapy regimen (excluding all topoisomerase I inhibitors e.g., HYCAMTIN and irinotecan).
• Subject is allowed to have received, but is not required to have received, one additional prior non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include, but are not limited to, monoclonal antibodies, cytokines, and small molecule inhibitors of signal transduction. UM2004/00031/00 CONFIDENTIAL HCT100414 20
• Subject is at least 21 days from prior chemotherapy and at least 30 days from prior non-cytotoxic therapy and is recovered from associated toxicities.
• Subject must not have received radiotherapy for at least seven days.

You may not qualify if:

• Subject is pregnant or lactating.
• Subject has received more than one prior chemotherapy regimen. UM2004/00031/00 CONFIDENTIAL HCT100414 21
• Subject has concomitant or history of previous malignancies, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for five years.
• Subject has active uncontrolled infection.
• Subject has brain metastases as documented by CT or MRI. Note: Asymptomatic subjects do not require CT or MRI to rule out brain metastases.
• Subject has received prior treatment with HYCAMTIN.
• Subject has a history of an allergic reaction to compounds chemically-related to HYCAMTIN or its constituents.
• Subject has received any investigational agent within 30 days or five half-lives (whichever is longer) prior to study entry.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (24)

GSK Investigational Site

La Jolla, California, 92037, United States

Location

GSK Investigational Site

Los Angeles, California, 90033, United States

Location

GSK Investigational Site

Newport Beach, California, 92663, United States

Location

GSK Investigational Site

Engelwood, Colorado, 80113, United States

Location

GSK Investigational Site

Coral Gables, Florida, 33146, United States

Location

GSK Investigational Site

Lakeland, Florida, 33805, United States

Location

GSK Investigational Site

Miami, Florida, 33143, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Hinsdale, Illinois, 60521, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55455, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68510, United States

Location

GSK Investigational Site

Columbia, South Carolina, 29210, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29605, United States

Location

GSK Investigational Site

Chattanooga, Tennessee, 37403, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37917, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

GSK Investigational Site

Calgary, Alberta, T2N 4N2, Canada

Location

GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4M1, Canada

Location

GSK Investigational Site

Québec, Quebec, G1R 2J6, Canada

Location

GSK Investigational Site

Debrecen, 4032, Hungary

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Limitations and Caveats

As there was only 1 responder, time to response, and duration of response were not calculated.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: December 21, 2005
• Study Start: October 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 11, 2012
• Results First Posted: January 28, 2010

Record last verified: 2012-06

Locations

US (19); HU (1); CA (4)