Expired Study
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Chicago, Illinois 60637


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have persistent or recurrent cancer of the cervix.


Study summary:

OBJECTIVES: - Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 15-37 patients will be accrued for this study within 1 year.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable - Eligible subtypes: - Adenocarcinoma - Adenosquamous carcinoma - Undifferentiated carcinoma - Must have documented disease progression - Histologic confirmation of original primary tumor required - Bidimensionally measurable disease - Ineligible for higher priority GOG protocol PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - Platelet count at least 100,000/mm^3 - Granulocyte count at least 1,500/mm^3 Hepatic: - Bilirubin no greater than 1.5 times normal - SGOT and alkaline phosphatase no greater than 3 times normal Renal: - Creatinine no greater than 1.5 mg/dL Other: - No significant infection - Not pregnant - Fertile patients must use effective contraception - No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent filgrastim (G-CSF) Chemotherapy: - No prior gemcitabine - At least 3 weeks since other prior chemotherapy for cervical cancer and recovered - No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy) Endocrine therapy: - Not specified Radiotherapy: - At least 3 weeks since prior radiotherapy for cervical cancer and recovered Surgery: - At least 3 weeks since prior surgery for cervical cancer and recovered Other: - No prior cancer treatment that would preclude study


Study is Available At:


Original ID:

CDR0000068144


NCT ID:

NCT00006224


Secondary ID:

GOG-0128F


Study Acronym:


Brief Title:

Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix


Official Title:

Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Gynecologic Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Russell J. Schilder, MD
Study Chair
Fox Chase Cancer Center

Study Dates

Start Date:September 2000
Primary Completion Date:April 2005
Primary Completion Type:Actual
Verification Date:June 2005
Last Changed Date:April 10, 2013
First Received Date:September 11, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:gemcitabine hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Gynecologic Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Schilder RJ, Blessing J, Cohn DE. Evaluation of gemcitabine in previously treated patients with non-squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2005 Jan;96(1):103-7.
PMID:15589587

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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