Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer

NCT00217581 | Completed Phase 2 Results DMC

• 5 other identifiers: CDR0000441641P30CA022453WSU-D-2840UMCC-2005-052AVENTIS-WSU-D-2840
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Esophageal Cancer; Gastric Cancer

Keywords

recurrent gastric cancer; stage III gastric cancer; stage IV gastric cancer; recurrent esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer; adenocarcinoma of the stomach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Response Rate by RECIST Criteria

  After every 2 cycles (1 cycle =21 days)

• Toxicity Profile

  At 21 days following completion of study treatment

• Time to Treatment Failure

  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

• Overall Survival

  Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years

Study Arms (1)

Docetaxel, Oxaliplatin & Bevacizumab

EXPERIMENTAL

Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.

Biological: Bevacizumab; Drug: Docetaxel; Drug: Oxaliplatin

Interventions

Bevacizumab BIOLOGICAL

Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.

Also known as: Avastin

Docetaxel, Oxaliplatin & Bevacizumab

Docetaxel DRUG

Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;

Also known as: Taxotere

Docetaxel, Oxaliplatin & Bevacizumab

Oxaliplatin DRUG

Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.

Also known as: Eloxatin

Docetaxel, Oxaliplatin & Bevacizumab

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201, United States

Location

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

Columbus, Ohio, 43210-1240, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Interventions

Bevacizumab; Docetaxel; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Limitations and Caveats

The trial completed its planned accrual. There were no significant limitations.

Results Point of Contact

• Title: Philip A. Philip, M.D., Ph.D., F.R.C.P
• Organization: Barbara Ann Karmanos Institute

philipp@karmanos.org

(313) 576-8746

Study Officials

• Philip A. Philip, MD, PhD, FRCP

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

• Basil El-Rayes, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• 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 20, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2004
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: March 26, 2019
• Results First Posted: July 7, 2014

Record last verified: 2019-03

Locations

US (4)