A Study of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer (APM4566g)

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00851136
First received: February 23, 2009
Last updated: June 29, 2010
Last verified: June 2010
  Purpose

This will be a multicenter, open-label study enrolling a total of up to 23 patients.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: bevacizumab
Drug: FOLFOX
Drug: PRO95780
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib Study of the Safety and Pharmacokinetics of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities [ Time Frame: Length and study ]

Secondary Outcome Measures:
  • Incidence, nature, and severity of adverse events [ Time Frame: Length of study ]
  • Change in vital signs [ Time Frame: Length of study ]
  • Incidence and severity of infusion reactions [ Time Frame: Length of study ]
  • Change in clinical laboratory results [ Time Frame: Length of study ]
  • Incidence of anti-PRO95780 antibodies [ Time Frame: Length of study ]

Enrollment: 9
Study Start Date: May 2009
Study Completion Date: June 2010
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab
Intravenous repeating dose
Drug: FOLFOX
Intravenous repeating dose
Drug: PRO95780
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease and measurable tumor lesions
  • Life expectancy > 3 months
  • For patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial and for 6 months following their final exposure to study treatment
  • Willingness and capability to be accessible for study follow-up

Exclusion Criteria:

  • Prior 5-FU, capecitabine, and/or oxaliplatin treatment with the exception of: prior oxaliplatin treatment≤ 6 weeks in the advanced or metastatic setting; prior treatment with 5-FU, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse occurred > 6 months from concluding adjuvant therapy
  • Peripheral neuropathy Grade ≥ 2
  • Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
  • Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1, or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1
  • Chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Cycle 1, Day 1
  • Evidence of clinically detectable ascites
  • Other invasive malignancies within 5 years prior to Cycle 1, Day 1
  • History or evidence upon physical examination of active central nervous system (CNS) disease
  • Current or recent participation in another experimental drug study
  • Clinically significant cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia within 1 year prior to Cycle 1, Day 1, or Grade II or greater peripheral vascular disease
  • Active infection requiring parenteral antibiotics
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle 1, Day 1, fine needle aspirations within 7 days prior to Cycle 1, Day 1, or anticipation of need for major surgical procedure during the course of the study
  • Known or suspected to be positive for the human immunodeficiency virus (HIV)
  • Known to be positive for hepatitis C or hepatitis B surface antigen
  • Inadequately controlled hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • History of arterial thromboembolic event 6 months prior to Cycle 1, Day 1
  • History of abdominal fistula or gastrointestinal perforation within 6 months prior to Cycle 1, Day 1
  • Bleeding diathesis or coagulopathy
  • Pregnancy (positive pregnancy test) or breast feeding
  • Serious, non-healing wound, ulcer, or bone fracture
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851136

Sponsors and Collaborators
Genentech
Investigators
Study Director: Chia Portera, M.D. Genentech
  More Information

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00851136     History of Changes
Other Study ID Numbers: APM4566g
Study First Received: February 23, 2009
Last Updated: June 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
CRC
Colon cancer
Avastin
APM4566g

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014