Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer

NCT00107315 | Terminated Phase 2 Results

• 3 other identifiers: I 22204RPCI-I-22204GENENTECH-RPCI-I-22204
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, 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 capecitabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with capecitabine works as first-line therapy in treating older patients with metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  1 year

Secondary Outcomes (3)

• Response Rate

  1 year

• Median Survival

  1 year

• Toxicity

  1 year

Study Arms (1)

Arm 1

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7

Biological: bevacizumab; Drug: capecitabine

Interventions

bevacizumab BIOLOGICAL

Arm 1

capecitabine DRUG

Arm 1

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically\* or cytologically\* confirmed colorectal cancer * Site of primary tumor must have been confirmed by endoscopy, radiography, or surgery * Metastatic disease NOTE: \*Patients with a history of surgically treated colorectal cancer who subsequently develop recurrent metastatic disease do not require histologic or cytologic confirmation of metastatic disease unless an interval of \> 5 years has elapsed between initial primary surgery and the development of metastases * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No known curative therapy exists * No history or evidence of CNS disease by physical exam (e.g., primary brain tumor or brain or CNS metastases) PATIENT CHARACTERISTICS: Age * 70 and over Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * No bleeding diathesis or coagulopathy Hepatic * Bilirubin normal * AST and ALT ≤ 3 times upper limit of normal (ULN) * INR \< 1.5 (unless on therapeutic anticoagulants) * No unstable or uncompensated hepatic disease Renal * Creatinine \< 1.2 times ULN OR * Creatinine clearance \> 60 mL/min * No unstable or uncompensated renal disease Cardiovascular * No history of stroke * No uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg on medication) * No myocardial infarction within the past year * No New York Heart Association class II-IV congestive heart failure * No unstable angina * No serious cardiac dysrhythmia requiring medication * No other clinically significant cardiovascular disease * No other unstable or uncompensated cardiac disease Pulmonary * No unstable or uncompensated respiratory disease Other * Fertile patients must use effective contraception * Able to receive oral medication * No known hypersensitivity to fluorouracil or capecitabine * No known dihydropyrimidine dehydrogenase deficiency * No seizures not controlled by standard medical therapy * No serious nonhealing wound, ulcer, or bone fracture * No other malignancy within the past 5 years except completely excised nonmelanoma skin cancer (with no evidence of recurrent disease) or carcinoma in situ of the cervix * No other severe or uncontrolled systemic disease PRIOR CONCURRENT THERAPY: Biologic therapy * No prior bevacizumab Chemotherapy * Prior adjuvant fluorouracil and leucovorin calcium allowed provided the last treatment was administered \> 6 months before the development of metastatic disease * No prior chemotherapy for metastatic colon cancer * No prior irinotecan or oxaliplatin Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics * More than 28 days since prior and no concurrent major surgery * More than 28 days since prior open biopsy * More than 7 days since prior fine needle aspiration or core biopsy Other * More than 4 weeks since prior and no concurrent participation in another experimental drug study * More than 30 days since prior non-approved or investigational drugs

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Marwan Fakih, MD

  Roswell Park Cancer Institute

  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: April 5, 2005
• First Posted: April 6, 2005
• Study Start: July 1, 2004
• Primary Completion: June 1, 2008
• Last Updated: July 4, 2014
• Results First Posted: July 4, 2014

Record last verified: 2014-06

Locations

US (1)