Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers

NCT01229111 | Terminated Phase 2 Results DMC

• 6 other identifiers: NCI-2011-02535CDR0000687126CASE 92098323N01CM00070U01CA062502
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 7

Brief Summary

This phase II trial is studying how well giving cediranib maleate together with combination chemotherapy works in treating patients with advanced biliary cancers. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cediranib maleate together with combination chemotherapy may kill more tumor cells.

Conditions

Adult Primary Cholangiocellular Carcinoma; Advanced Adult Primary Liver Cancer; Cholangiocarcinoma of the Extrahepatic Bile Duct; Cholangiocarcinoma of the Gallbladder; Localized Unresectable Adult Primary Liver Cancer; Periampullary Adenocarcinoma; Recurrent Adult Primary Liver Cancer; Recurrent Extrahepatic Bile Duct Cancer; Recurrent Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer; Unresectable Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

• The Response Rate of Patients Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  The number of patients with a Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

  Up to 3 years

Secondary Outcomes (4)

• Tabulation of the Toxicity Profile of the Combination Therapy

  Up to 3 years

• Progression Free Survival

  Up to 3 years

• Estimation of Overall Survival

  Up to 3 years

• Identification of Factors That Predict Survival

  Up to three years

Study Arms (1)

Treatment (cediranib maleate and modified FOLFOX)

EXPERIMENTAL

Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.

Drug: cediranib maleate; Drug: oxaliplatin; Drug: leucovorin calcium; Drug: fluorouracil

Interventions

cediranib maleate DRUG

Given PO

Also known as: AZD2171, Recentin

Treatment (cediranib maleate and modified FOLFOX)

oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Treatment (cediranib maleate and modified FOLFOX)

leucovorin calcium DRUG

Given IV

Also known as: CF, CFR, LV

Treatment (cediranib maleate and modified FOLFOX)

fluorouracil DRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

Treatment (cediranib maleate and modified FOLFOX)

Eligibility Criteria

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

You may qualify if:

• Patients with histopathological or cytopathological diagnosis of advanced biliary carcinoma (gallbladder cancer, cholangiocarcinoma, ampullary cancer) not amenable to conventional surgical approach are eligible
• Patients 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
• No patients with untreated brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
• Life expectancy of greater than 12 weeks
• White blood cell (WBC)/leukocytes ≥ 3,000/μL
• Absolute neutrophil count ≥ 1,500/μL
• Platelets ≥ 100,000/μL
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 3 mg/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) ≤ 2.5 times institutional upper limit of normal
• Creatinine within normal institutional limits OR calculated creatinine clearance ≥ 60 mL/min
• No patients with proteinuria not meeting the criteria below; urine sample must be tested by urine protein:creatinine (UPC) ratio or by urinalysis method within 1 week of starting study treatment; depending upon the testing method used, the following criteria must be met:
• UPC ratio must be \< 1.0; if UPC ratio is ≥ 1.0, a 24-hour urine specimen must be collected and must demonstrate \< 1 g of protein
• Urinalysis must indicate 0-1+ protein; if urinalysis reading is ≥ 2+, a 24-hour urine specimen must be collected and must demonstrate \< 1 g of protein

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (7)

Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Ireland Cancer Center Landerbrook Health Center

Mayfield Heights, Ohio, 44124, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

UHHS-Chagrin Highlands Medical Center

Orange, Ohio, 44122, United States

Location

UH-Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, 44145, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

cediranib; Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Smitha Krishnamurthi
• Organization: Case Comprehensive Cancer Center

smitha.krishnamurhti@uhhospitals.org

216-844-5234

Study Officials

• Smitha Krishnamurthi

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (7)