Irinotecan and Capecitabine as Second-line Treatment for Advanced/Metastatic Biliary Tract Cancers

NCT02720601 | Withdrawn Phase 2 DMC

• 1 other identifier: INST 1417
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Biliary tract cancers that progress after first line treatment can be difficult to treat. There is a great need for an effective, tolerable, easy to administer second-line regimen. Previous early phase studies demonstrated that the combination of two chemotherapy drugs, irinotecan and capecitabine had activity in this setting. The goal of this study is to determine whether this drug combination, as a second-line treatment, can improve progression free survival in patients with biliary tract cancers.

Conditions

Biliary Tract Cancer

Keywords

irinotecan; capecitabine; gemcitabine; biliary tract cancer; gallbladder cancer; second-line

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  The time from initiation of treatment to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Progressive disease (PD) for target lesions: \>= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions.The Kaplan-Meier method will be used to calculate the proportion of subjects who are progression-free at 6 months along with its 95% confidence interval. Subjects lost to follow-up or who withdraw from the study for any reason will be censored at their last date of contact

  6 months from the time of initiating treatment

Secondary Outcomes (3)

• Overall response rate (ORR)

  Up to 6 months after initiating treatment

• Overall Survival (OS)

  36 months from enrollment

• Toxicity

  Up to 30 days after last on-study treatment

Study Arms (1)

Irinotecan & Capecitabine

EXPERIMENTAL

Irinotecan at 120 mg/m2 intravenously every three weeks + Capecitabine at 1500 mg/m2/day orally twice per day for a total of 14 days. The treatment cycle is once every 21 days.

Drug: Irinotecan & Capecitabine

Interventions

Irinotecan & Capecitabine DRUG

Irinotecan will be administered at infusion room over 60 minutes. Capecitabine will be administered by the patients at home. Unless there is early progression of disease, at least two courses will be administered to each patient. Repeated courses may be given to the patients who benefit from the treatment (either complete or partial remission, or stabilization of disease)

Also known as: Irinotecan = Camptosar, Campto, or CPT-11 (Camptothecin-11), Capecitabine = Xeloda

Irinotecan & Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 years of age or older
• Histological proven un-resectable or metastatic biliary tract cancer (gallbladder cancer included) with radiologic progression after initial gemcitabine plus platinum (cisplatin, carboplatin or oxaliplatin) regimen
• Computerized tomography (CT) or magnetic resonance imaging (MRI) with measurable lesions no more than 28 days prior to enrollment. Lesions should be at least 1.5 cm in longest dimension.
• Patients with evaluable only disease, effusion, needs to have cytology proven malignant cells present in the effusion.
• Patients who cannot tolerate or developed allergic reaction to either gemcitabine or platinum compounds, even without radiographic progression will be eligible.
• Patients must have a life expectancy of at least 12 weeks
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
• Patients must be able to understand and sign informed consent.
• Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of ≥ 1,500 cells/mm3 and platelet count ≥ 60,000/mm3 and absence of a regular red blood cell transfusion requirement.
• Patients should have adequate hepatic function with a total bilirubin ≤ 4.0 mg/dl, could be ≤ 10 mg/dl if a functional biliary drain is placed within three days of enrollment and documented declining total bilirubin level, and adequate renal function as defined by a serum creatinine ≤ 1.5 X upper limit of normal.
• Patients with concurrent basal cell carcinoma and/or squamous cell carcinoma of skin are eligible.
• Patients with other malignancies require having at least 5 year disease-free interval before enrollment
• Patients who were treated with either irinotecan and/or capecitabine for cancers other than biliary tract cancer are eligible as long as treatment-free interval is greater than 3 years.

You may not qualify if:

• Patients with symptomatic central nervous system (CNS) metastases are excluded. Need to demonstrate stable CNS metastases for at least 3 months
• Pregnant women and nursing mothers are not eligible.
• Patients of child bearing potential must agree to use adequate contraception
• No heart attack within 6 months of enrollment
• No stroke (embolic and hemorrhage) within 6 months of enrollment.
• No New York Heart Association Class III/IV congestive heart failure (CHF).
• Severe chronic obstructive pulmonary disease (COPD) requires ≥ 2 L (Liters) /minute of oxygen.
• Known history of allergic reaction to irinotecan and/or capecitabine.
• Known history of 5-fluorouracil (5-FU) or capecitabine induced cardiac toxicity.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

Universtiy of New Mexico - Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms; Gallbladder Neoplasms

Interventions

Irinotecan; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Fa-Chyi Lee, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 28, 2016
• Study Start: November 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2020
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

US (1)