Gemox as First and Second Line Therapy in Unknown Primary Cancer
|ClinicalTrials.gov Identifier: NCT00353145|
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : August 2, 2012
- To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer (UPC).
- To determine the tolerability (toxicity) of this regimen in this patient population.
- To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
- To determine the impact of this combination on quality of life (QOL) in this patient population.
|Condition or disease||Intervention/treatment||Phase|
|Unknown Primary Neoplasms||Drug: Gemcitabine (Gemox) Drug: Oxaliplatin Behavioral: Questionnaire||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Evaluate the Efficacy and Toxicity of Oxaliplatin in Combination With Gemcitabine as First and Second Line Therapy in Unknown Primary Cancer|
|Study Start Date :||February 2004|
|Primary Completion Date :||March 2007|
|Study Completion Date :||January 2010|
Experimental: Gemcitabine + Oxaliplatin
Gemcitabine 1000 mg/m^2, infused at 10 mg/m^2/min on Day 1 and Oxaliplatin 100 mg/m^2 by vein infused on Day 2 over two hours. Repeated every 14 days (one cycle).
Drug: Gemcitabine (Gemox)
1000 mg/m^2, infused at 10 mg/m^2/min on Day 1 repeated every 14 days (one cycle).
Other Names:Drug: Oxaliplatin
100 mg/m^2 by vein infused on Day 2 over two hours, repeated every 14 days (one cycle).
Other Name: EloxatinBehavioral: Questionnaire
Quality of Life Surveys
- Participants' Response [ Time Frame: Response to treatment measured using Response Evaluation Criteria in Solid Tumors (RECIST) criteria with radiological evaluation at 6 weeks and reevaluated every 6 weeks. ]Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor increase to qualify for PD, reference smallest sum LD since treatment started.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353145
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gauri R. Varadhachary, MD||M.D. Anderson Cancer Center|