A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma

NCT02256982 | Terminated Results DMC

• 1 other identifier: 14-275
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating the use of radiation therapy in combination with chemotherapy as a possible treatment for intrahepatic cholangiocarcinoma, a rare form of gastrointestinal cancer.

Conditions

Unresectable Intrahepatic Cholangiocarcinoma; Resectable Intrahepatic Cholangiocarcinoma

Keywords

unresectable intrahepatic cholangiocarcinoma; resectable intrahepatic cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants Post Operative/Radiation Therapy Complications

  Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.

  90 Days

Study Arms (2)

Resectable Disease

EXPERIMENTAL

* Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery\* (weeks 10-15) \-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to surgery * Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist

Drug: Gemcitabine; Drug: Cisplatin; Procedure: Surgery

Unresectable Disease

EXPERIMENTAL

* Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery\* (weeks 10-15) * Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to radiation therapy with protons or photons, determined by available resources * Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist

Drug: Gemcitabine; Drug: Cisplatin; Radiation: Radiation

Interventions

Gemcitabine DRUG

Also known as: Gemzar

Resectable Disease; Unresectable Disease

Cisplatin DRUG

Also known as: Platinol®, Platinol-AQ®, cis-DDP, cis-Platinum II, cis-Diamminedichloroplatinum, DDP

Resectable Disease; Unresectable Disease

Surgery PROCEDURE

Surgical Resection and Lymphadenectomy

Resectable Disease

Radiation RADIATION

Radiation Therapy

Unresectable Disease

Eligibility Criteria

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

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Participants must have histologically confirmed Intrahepatic Cholangiocarcinoma (IHC) without evidence of extrahepatic metastasis.
• Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan.
• Participants with resectable disease must have a single tumor (with no satellite lesions) with a total diameter or longest dimension of ≤ 20cm. Patients with unresectable disease must have a total tumor diameter of \<20cm and ≤ 3 lesions. Satellite lesions defined as lesions ≤ 2cm from the dominant lesion are permitted for participants with unresectable disease
• Patients are not allowed to receive prior surgery or chemotherapy for the IHC.
• Patients with age ≥18 will be included in the study.
• Expected survival must be three months or greater.
• ECOG performance status ≤ 2 (Karnofsky ≥ 70%, see Appendix A).
• Participants must have normal organ and marrow function as defined below:
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Total bilirubin ≤ 2.5 mg/dl
• AST (SGOT)/ALT (SGPT) ≤ 5.0 X institutional upper limit of normal
• Creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal .
• No other known active secondary primary malignancy.

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Participants who have had chemotherapy or radiotherapy for intrahepatic cholangiocarcinoma.
• Participants receiving any other anti-cancer or investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or cisplatin.
• Women who are pregnant or lactating.
• Participants with evidence of non-hepatic metastatic disease.
• Local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc.
• Participants with a serious medical illness which may limit expected survival to less than 3 months.
• Participants with serious psychiatric illness or social situations which would limit adherence to study requirements.
• Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible.
• Because no dosing or adverse event data are currently available on the use of gemcitabine+cisplatin in participants \<18 years of age, children are excluded from this study.
• Patients who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because gemcitabine is a class D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with gemcitabine, breastfeeding should be discontinued if the mother is treated with gemcitabine. These potential risks may also apply to other agents used in this study.
• Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, DCIS, stage I prostate cancer, and basal cell or squamous cell carcinoma of the skin.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Gemcitabine; Cisplatin; Surgical Procedures, Operative; Radiation

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena

Results Point of Contact

• Title: Ted Hong, MD
• Organization: Massachusetts General Hospital

tshong1@partners.org

617-726-6050

Study Officials

• Theodore S. Hong, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 6, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 13, 2016
• Results First Posted: April 13, 2016

Record last verified: 2016-04

Locations

US (1)