NCT02042443|CompletedPhase 2Results

Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery

S1310

Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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5 other identifiers

NCI-2013-02485S1310SWOG-S1310U10CA180888U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

295

Timeline

RegisteredJan 2014

StartedFeb 2014

CompletionApr 2017

Brief Summary

This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving trametinib is more effective than combination chemotherapy in treating patients with biliary or gallbladder cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach

1 country

295 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

First Submitted

Initial submission to the registry

January 20, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed

10 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed

3 months until next milestone

Results Posted

Study results publicly available

August 10, 2017

Completed

Last Updated

September 12, 2017

Status Verified

August 1, 2017

Enrollment Period

2.9 years

First QC Date

January 20, 2014

Results QC Date

July 12, 2017

Last Update Submit

August 11, 2017

Conditions

Adult Cholangiocarcinoma Advanced Adult Hepatocellular Carcinoma BCLC Stage C Adult Hepatocellular Carcinoma BCLC Stage D Adult Hepatocellular Carcinoma Hilar Cholangiocarcinoma Localized Non-Resectable Adult Liver Carcinoma Recurrent Adult Liver Carcinoma Recurrent Childhood Liver Cancer Recurrent Extrahepatic Bile Duct Carcinoma Recurrent Gallbladder Carcinoma Stage II Gallbladder Cancer Stage III Childhood Hepatocellular Carcinoma Stage IIIA Gallbladder Cancer Stage IIIB Gallbladder Cancer Stage IV Childhood Hepatocellular Carcinoma Stage IV Distal Bile Duct Cancer Stage IVA Gallbladder Cancer Stage IVB Gallbladder Cancer Unresectable Extrahepatic Bile Duct Carcinoma

Outcome Measures

Primary Outcomes (1)

Overall Survival
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Up to 2 years from registration

Secondary Outcomes (3)

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Up to 2 years
Objective Response Rate
Up to 2 years from registration
Progression-free Survival
Up to 2 years from registration

Study Arms (2)

Trametinib

EXPERIMENTAL

Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: Trametinib

Chemotherapy

EXPERIMENTAL

Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15 (courses repeat every 28 days); or B) capecitabine PO BID on days 1-14 (courses repeat every 21 days). Patients treated until disease progression or unacceptable toxicity.

Drug: CapecitabineDrug: FluorouracilOther: Laboratory Biomarker AnalysisDrug: Leucovorin Calcium

Interventions

CapecitabineDRUG

Given PO

Also known as: Ro 09-1978/000, Xeloda

Chemotherapy

FluorouracilDRUG

Given IV

Also known as: 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Chemotherapy

Laboratory Biomarker AnalysisOTHER

Correlative studies

ChemotherapyTrametinib

Leucovorin CalciumDRUG

Given IV

Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

Chemotherapy

TrametinibDRUG

Given PO

Also known as: GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Mekinist

Trametinib

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

DISEASE RELATED CRITERIA
Patients must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease; patients with ampullary carcinoma are not eligible
Patients must have measurable disease; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
PRIOR/CONCURRENT THERAPY CRITERIA
Patients must have completed any prior chemotherapy at least 21 days prior to registration and have recovered from any of the effects AND
Patients must have experienced progression to no more than 1 prior regimen of systemic chemotherapy for advanced biliary cancer OR
Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible; if patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing one regimen of systemic chemotherapy used to treat the (unresectable or metastatic) disease recurrence
Patients must not have been treated with prior MEK inhibitors; prior 5-FU or capecitabine treatment is allowed only if given as a radiosensitizer concurrently with radiation therapy at least 12 weeks prior to registration or if given as part of any adjuvant therapy regimen \>= 12 months prior to study enrollment
Patients must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy (including herbal or natural supplements) for treatment of cancer while on this treatment protocol
For patients who have received prior cryotherapy, radiation therapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met:
days have elapsed since that therapy (lesions that have not been treated with local therapy must be present and measureable)
CLINICAL/LABORATORY CRITERIA
Patients must have a Zubrod performance status of 0-1
Absolute neutrophil count (ANC) \> 1000/mcL
Platelets \> 100000/mcL
+27 more criteria

Contact the study team to confirm eligibility.