S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cance… (NCT00033540) | Clinical Trial Compass
CompletedPhase 2
S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma
United States57 participantsStarted 2003-09
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have locally advanced or metastatic gallbladder cancer or cholangiocarcinoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed gallbladder cancer or cholangiocarcinoma
* Locally advanced or metastatic disease that is unresectable
* Eligible subtypes:
* Adenocarcinoma, intestinal type
* Adenocarcinoma, not otherwise specified (NOS)
* Papillary carcinoma
* Clear cell adenocarcinoma
* Mucinous carcinoma
* Signet ring cell carcinoma
* Squamous cell carcinoma
* Adenosquamous carcinoma
* Small cell carcinoma
* Undifferentiated carcinoma
* Carcinoma, NOS
OR
* Histologically confirmed adenocarcinoma of a metastatic site with clinical documentation\* of gallbladder or bile duct involvement and no evidence of another primary
NOTE: \*If clinical documentation of gallbladder or bile duct involvement is not possible due to removal of the organ, a clinically and/or radiographically consistent picture plus pathologic findings from the metastatic site consistent with cholangiocarcinoma are allowed
* Measurable disease located outside prior radiotherapy port
* No carcinoid tumors or sarcomas
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 3 times upper limit of normal (ULN)
* Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) no greater than 2…
What they're measuring
1
Response
Timeframe: Patients assessed at least every six weeks while on protocol treatment