Clinical trial · Interventional

S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma

A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma

NCT00033540CI-TRIAL-00029491completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Extrahepatic Bile Duct Cancer	Malignant Extrahepatic Bile Duct Neoplasm	ALIAS	0.90
Gallbladder Cancer	Malignant Gallbladder Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
capecitabine	Drug	Capecitabine	ALIAS
gemcitabine hydrochloride	Drug	Gemcitabine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Capecitabine + Gemcitabine
description
Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
interventionNames
1. Drug: capecitabine
2. Drug: gemcitabine hydrochloride

Primary outcomes (1)

measure
Response
timeFrame
Patients assessed at least every six weeks while on protocol treatment
description
Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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 2.5 times ULN (5 times ULN if liver metastasis is present)

Renal:

* Creatinine clearance at least 30 mL/min

Cardiovascular:

* No clinically significant cardiac disease that is not well controlled by medication
* No congestive heart failure
* No symptomatic coronary artery disease
* No cardiac arrhythmias
* No myocardial infarction within the past 12 months

Gastrointestinal:

* Able to swallow and/or receive medications via gastrostomy feeding tube
* No intractable nausea or vomiting
* No malabsorption syndrome

Other:

* No severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil
* No other malignancy within the past 5 years except:

  * Adequately treated basal cell or squamous cell skin cancer
  * Carcinoma in situ of the cervix
  * Adequately treated stage I or II cancer currently in complete remission
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior neoadjuvant or adjuvant immunotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease
* No concurrent immunotherapy

Chemotherapy:

* Prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease
* No other concurrent chemotherapy

Endocrine therapy:

* Prior neoadjuvant or adjuvant hormonal therapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease
* No concurrent hormonal therapy

Radiotherapy:

* See Disease Characteristics
* See Chemotherapy
* Recovered from prior radiotherapy
* Prior neoadjuvant or adjuvant radiotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease
* No prior radiotherapy to 25% or more of bone marrow
* No concurrent radiotherapy except for palliation of metastatic sites not considered target lesions

Surgery:

* At least 2 weeks since prior surgery for this malignancy and recovered

Other:

* No prior treatment for metastatic disease
* No other concurrent therapy for this cancer

References

Publications (2)

BACKGROUNDLurje G, Zhang W, Yang D, Groshen S, Hendifar AE, Husain H, Nagashima F, Chang HM, Fazzone W, Ladner RD, Pohl A, Ning Y, Iqbal S, El-Khoueiry A, Lenz HJ. Thymidylate synthase haplotype is associated with tumor recurrence in stage II and stage III colon cancer. Pharmacogenet Genomics. 2008 Feb;18(2):161-8. doi: 10.1097/FPC.0b013e3282f4aea6. PMID 18192902
RESULTIqbal S, Rankin C, Lenz HJ, Gold PJ, Ahmad SA, El-Khoueiry AB, Messino MJ, Holcombe RF, Blanke CD. A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202. Cancer Chemother Pharmacol. 2011 Dec;68(6):1595-602. doi: 10.1007/s00280-011-1657-1. Epub 2011 May 10. PMID 21556747

Registry

Dates and enrollment

Start: Sep 1, 2003
Primary completion: Apr 1, 2008
Completion: Jul 1, 2011
First posted: Jan 27, 2003
Last update posted: Sep 12, 2017
Results first posted: Aug 28, 2012
Enrollment: 57 (actual)
Lead sponsor: SWOG Cancer Research Network NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: unresectable gallbladder cancer, recurrent gallbladder cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, adenocarcinoma of the gallbladder, adenocarcinoma with squamous metaplasia of the gallbladder, squamous cell carcinoma of the gallbladder, adenocarcinoma of the extrahepatic bile duct, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct

Data updated 22 days agoSource updated Sep 12, 2017source: clinicaltrials

Locations

Locations by country (112)

Country	Sites	Recruiting