Gastric Cancer Clinical Trial
Official title:
Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer
Verified date | March 2019 |
Source | Barbara Ann Karmanos Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of
tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as
oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from dividing. Giving bevacizumab together with
oxaliplatin and docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with
oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or
metastatic stomach or gastroesophageal junction cancer.
Status | Completed |
Enrollment | 39 |
Est. completion date | January 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed gastric or gastroesophageal junction adenocarcinoma - Locally advanced unresectable or metastatic disease - Measurable disease, defined as = 1 unidimensionally measurable lesion = 20 mm by conventional techniques OR = 10mm by spiral CT scan - Bone metastases, ascites, or pleural effusions are not considered measurable disease - Evaluable disease must be present outside previously irradiated field - No CNS or brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - SWOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count = 1,500/mm^3 - Platelet count = 100,000/mm^3 - Hemoglobin = 10 mg/dL - No evidence of bleeding diathesis or coagulopathy Hepatic - AST and ALT = 2.5 times upper limit of normal (ULN) - Alkaline phosphatase = 2.5 times ULN - Bilirubin = ULN - INR < 1.5 Renal - Creatinine < 2.0 mg/dL - Urine protein:creatinine ratio < 1.0 Cardiovascular - No history of deep venous thrombosis requiring anticoagulation - No active angina - No myocardial infarction within the past year - No cerebrovascular accident within the past year - No uncontrolled hypertension (systolic blood pressure [BP] > 170 mm Hg and/or diastolic BP > 100 mm Hg) despite medical management Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after completion of study treatment - No peripheral neuropathy > grade 1 - No history of allergy to any of the study drugs or drugs formulated with polysorbate 80 - No known HIV infection - No active peptic ulcer disease - No serious non-healing wound, ulcer, or bone fracture - No unresolved bacterial infection requiring antibiotics - No other active malignancy within the past 3 years except for cancers that have been treated with a curative intent PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy Chemotherapy - No prior chemotherapy for gastric cancer unless disease relapsed > 6 months after completion of non-taxane adjuvant chemotherapy - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 3 weeks since radiotherapy Surgery - At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter placement) - No concurrent surgery Other - At least 4 weeks since prior and no concurrent participation in another experimental drug trial - No concurrent full-dose anticoagulation - No concurrent experimental drugs |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Veterans Affairs Medical Center - Detroit | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Progression | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months | |
Secondary | Response Rate by RECIST Criteria | Percentage of Participants with response by RECIST criteria until progression | After every 2 cycles (1 cycle =21 days) | |
Secondary | Toxicity Profile | Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading. | At 21 days following completion of study treatment | |
Secondary | Time to Treatment Failure | Time to treatment failure using the Kaplan-Meier method | Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | |
Secondary | Overall Survival | Overall survival using the Kaplan-Meier method | Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05551416 -
The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
|
||
Completed |
NCT05518929 -
Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients
|
Phase 4 | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03219593 -
Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT05536102 -
The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Active, not recruiting |
NCT04082364 -
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
|
Phase 2/Phase 3 | |
Withdrawn |
NCT03766607 -
Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT01924533 -
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
|
Phase 3 | |
Terminated |
NCT01641939 -
A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
Active, not recruiting |
NCT04908813 -
Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04249739 -
Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive
|
Phase 2 | |
Recruiting |
NCT05514158 -
To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG)
|
Phase 1 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 |