Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer

NCT00702884 | Completed Phase 2 Results DMC

• 2 other identifiers: OSU-07121NCI-2011-03148
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory esophageal or gastroesophageal junction cancer.

Conditions

Esophageal Cancer

Keywords

recurrent esophageal cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer; stage IV esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate

  Complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks

  up to 24 weeks

Secondary Outcomes (6)

• Overall Response Rate

  up to 4 years

• Median Overall Survival Time

  up to 4 years

• Median Progression-free Survival Time

  up to 4 years

• Frequency and Severity of Adverse Events

  up to 4 years

• Change in Mean Vessel Density

  up to 4 years

Study Arms (1)

Sunitinib

EXPERIMENTAL

Sunitinib 37.5 mg daily for a 4 week cycle

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

Sunitinib 37.5 mg daily for a 4 week cycle

Also known as: Sutent, SU011248 L-Malate salt, SU010398, PHA-290940AD, SU011248

Sunitinib

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed esophageal or gastroesophageal junction carcinoma that is not amenable to curative surgery or other curative therapy * Advanced, relapsed or refractory disease * 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 by conventional techniques or as ≥ 10 mm by spiral CT scan * No known brain metastases PATIENT CHARACTERISTICS: * ECOG (Eastern Cooperative Oncology Group) performance status 0-1 * Life expectancy \> 12 weeks * WBC ≥ 3,000/μL * Absolute neutrophil count ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Serum calcium ≤ 12.0 mg/dL * Total bilirubin normal * AST (aspartate aminotransferase) and ALT (Alanine Aminotransferase) ≤ 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception prior to, during, and for 28 days after completion of study treatment * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate * No ongoing cardiac dysrhythmias ≥ grade 2, atrial fibrillation of any grade, or prolongation of the QTc (corrected QT interval) interval to \> 450 msec (for males) or \> 470 msec (for females) * No hypertension that cannot be controlled by medications (i.e., systolic/diastolic blood pressure \> 150/100 mm Hg despite optimal medical therapy) * No myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months * No cerebrovascular accident or transient ischemic attack within the past 12 months * No pulmonary embolism within the past 12 months * No condition that would impair the ability to swallow and retain sunitinib malate tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days * No serious or nonhealing wound, ulcer, or bone fracture * No pre-existing thyroid abnormality that cannot be maintained in the normal range with medication * No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * At least 4 weeks since prior radiotherapy or major surgery * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C, carmustine, or alkylating agents) * No more than 6 prior courses of an alkylating agent * No more than 450 mg/m² of prior doxorubicin hydrochloride or 900 mg/m² of prior epirubicin hydrochloride * No more than 2 lines of prior therapy in the metastatic setting * No prior anti-VEGF monoclonal antibodies, such as bevacizumab or aflibercept * No prior tyrosine kinase inhibitors with similar targets (e.g., sorafenib tosylate or axitinib) * No other concurrent investigational agents * No concurrent therapeutic doses of coumarin-derivative anticoagulants, such as warfarin * Warfarin at doses of ≤ 2 mg daily are allowed for prophylaxis of thrombosis * Low molecular weight heparin allowed provided PT/INR (Prothrombin time and international normalized ratio) is ≤ 1.5 * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent agents with proarrhythmic potential (e.g., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tony Bekaii-Saab: lead
• Pfizer: collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Wu C, Mikhail S, Wei L, Timmers C, Tahiri S, Neal A, Walker J, El-Dika S, Blazer M, Rock J, Clark DJ, Yang X, Chen JL, Liu J, Knopp MV, Bekaii-Saab T. A phase II and pharmacodynamic study of sunitinib in relapsed/refractory oesophageal and gastro-oesophageal cancers. Br J Cancer. 2015 Jul 14;113(2):220-5. doi: 10.1038/bjc.2015.197. Epub 2015 Jul 7.

  PMID: 26151457 RESULT

Related Links

• Jamesline

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Tanios Bekaii-Saab
• Organization: The Ohio State University Comprehensive Cancer Center

Tanios.Bekaii-Saab@osumc.edu

614-293-6529

Study Officials

• Tanios Bekaii-Saab, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• 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: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: June 30, 2008
• Primary Completion: September 17, 2013
• Study Completion: December 30, 2013
• Last Updated: March 21, 2017
• Results First Posted: March 21, 2017

Record last verified: 2017-01

Locations

US (1)