Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma

NCT00780494 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB-1191198587SU-07082008-1238GI0002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate bevacizumab in combination with carboplatin and capecitabine for patients with unresectable or metastatic GEJ or gastric cancers. We hope that by adding bevacizumab to standard chemotherapy for this patient population we will improve Progression Free Survival by 90% over historical controls.

Conditions

Stomach Cancer; Gastric (Stomach) Cancer; Neoplasm of Cardioesophageal Junction; Gastrointestinal Stromal Tumor (GIST)

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Tumor progression was assessed according to the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), presented below. * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Objective Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria. Progression-Free Survival is assessed as the number of evaluable participants who were alive without disease progression at 1 year. Participants without out assessment at 12 months will not be included.

  12 months

Secondary Outcomes (5)

• Adverse Events ≥ Grade 3 and Related to Bevacizumab

  12 months

• Overall Survival (OS)

  7.5 years

• Objective (Overall) Therapeutic Response

  12 months

• CEA and CA 19.9 Tumor Response Biomarkers

  9 weeks

• Vascular Endothelial Growth Factor Tumor Response Biomarker

  9 weeks

Study Arms (1)

bevacizumab+ carboplatin +capecitabine

EXPERIMENTAL

Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.

Drug: bevacizumab; Drug: carboplatin; Drug: capecitabine

Interventions

bevacizumab DRUG

Intravenous 15 mg/kg

Also known as: Avastin

bevacizumab+ carboplatin +capecitabine

carboplatin DRUG

AUC 6, Intravenously Day 1 every 21 days

Also known as: Paraplatin

bevacizumab+ carboplatin +capecitabine

capecitabine DRUG

850mg/m2, Orally twice daily days 1-14 every 21 days.

Also known as: Xeloda

bevacizumab+ carboplatin +capecitabine

Eligibility Criteria

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

You may qualify if:

• Subjects must be treated at Stanford University Medical Center for the entire length of study participation.
• Patients with histologically or cytologically confirmed adenocarcinoma of the GEJ or stomach.
• Patients must be deemed unresectable due to involvement of critical vasculature or adjacent organ invasion. If unresectable, patients must show evidence of disease progression prior to enrollment.
• Patients with prior surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of \> 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
• Prior carboplatin as neoadjuvant or adjuvant therapy will be allowed if \>= 6 months from the time of study entry.
• If patients use aspirin (\>325mg/day) or NSAIDS at the time of enrollment, they must have a 10 day washout period prior to beginning protocol treatment.
• Low molecular weight heparin (or its equivalent, excluding warfarin) will be allowed for treatment of venous thromboembolic events if patients have no evidence of bleeding on full-dose anticoagulation.
• Patients must have a primary or metastatic lesion measurable in at least one dimension by Modified RECIST criteria (see Section 11.2.3) within 4 weeks prior to entry of study
• Patients must have ECOG performance status of 0-1
• Patients must be \>= 18 years of age
• Laboratory values \<= 2 weeks prior to randomization:
• Absolute Neutrophil Count (ANC) \>= 1.5 x 109/L (\>= 1500/mm3)
• Platelets (PLT) \>= 100 x 109/L (\>= 100,000/mm3)
• Hemoglobin (Hgb) \>= 9 g/dL
• Serum creatinine \<= 1.5 x ULN

You may not qualify if:

• Ability to give written informed consent according to local guidelines
• Prior chemotherapy for metastatic disease
• Prior full field radiotherapy \<= 4 weeks or limited field radiotherapy \<= 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
• Prior biologic or immunotherapy \<= 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
• Prior therapy with anti-VEGF agents
• If history of other primary cancer, subject eligible only if she or he has:
• Curatively resected non-melanomatous skin cancer
• Curatively treated cervical carcinoma in situ
• Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years
• Concurrent use of other investigational agents and patients who have received investigational drugs \<= 4 weeks prior to enrollment.
• Hypersensitivity to capecitabine, fluorouracil, or any component of the formulation and or a known deficiency of dihydropyrimidine dehydrogenase.
• Subjects known to have chronic or active hepatitis B or C infection
• History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
• Male subject who is not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of second-line treatment
• Female subject (of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized, or not abstinent) who is not willing to use an oral, patch or implanted contraceptive, double-barrier birth control, or an IUD during the course of the study and for 6 months following the last dose of second-line treatment

Sponsors & Collaborators

• Stanford University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms; Gastrointestinal Stromal Tumors

Interventions

Bevacizumab; Carboplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Pamela Kunz
• Organization: Stanford University

pkunz@stanford.edu

650-725-8738

Study Officials

• Pamela Kunz, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: 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

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 27, 2008
• Study Start: February 1, 2009
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 14, 2025
• Results First Posted: September 18, 2019

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)