Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma
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|ClinicalTrials.gov Identifier: NCT00184093|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : August 15, 2017
Last Update Posted : August 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cervical Cancer||Drug: Gemcitabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma: Analysis of Prognostic Factors and Determinants of Response: A Pilot Study|
|Study Start Date :||June 1999|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2009|
Experimental: Gemcitabine weekly x 6 wks with concurrent external radiation
Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
Gemcitabine weekly x 6 wks with concurrent external radiation
- Toxicity (Number of Participants With Serious Adverse Events) [ Time Frame: Every 3 weeks from start of study until 30 days after the last dose of treatment ]Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)
- Best Overall Response of Either a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to response (up to 24 months) ]
Participants who complete the 6 weeks of chemotherapy and radiation or who experience dose limiting toxicity or who progress at any time prior to completion of the 6 weeks of chemotherapy and radiation will be evaluable for response.
Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of nonevaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable, and nonevaluable lesions and sites must be assessed using the same technique as baseline.
Partial response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184093
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Lynda Roman, MD||University of Southern California|