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A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00497497
First received: July 3, 2007
Last updated: February 15, 2011
Last verified: February 2011
  Purpose

This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab.


Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab
Drug: cetuximab
Drug: FOLFIRI regimen
Drug: irinotecan
Drug: PRO95780
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib, Dose-Escalation Study of the Safety and Pharmacokinetics of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities [ Time Frame: Through study completion or early study discontinuation ]

Secondary Outcome Measures:
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
  • Change in vital signs [ Time Frame: Through study completion or early study discontinuation ]
  • Incidence and severity of infusion reactions [ Time Frame: Through study completion or early study discontinuation ]

Enrollment: 20
Study Start Date: October 2007
Arms Assigned Interventions
Experimental: 1 Drug: cetuximab
Intravenous repeating dose
Drug: irinotecan
Intravenous repeating dose
Drug: PRO95780
Intravenous repeating dose
Experimental: 2 Drug: bevacizumab
(Only for patients not previously treated with bevacizumab) Intravenous repeating dose
Drug: FOLFIRI regimen
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:

  • Signed informed consent
  • Age ≥ 18 years
  • Histologically confirmed CRC with evidence of metastases and measurable tumor lesions
  • Documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy
  • Life expectancy > 3 months
  • For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) 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:

  • Patients who have a Kras mutation will be excluded from receiving cetuximab-containing regimens
  • Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
  • Recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field
  • Recent chemotherapy, hormonal therapy, or immunotherapy
  • Evidence of clinically detectable ascites
  • Other invasive malignancies within 5 years
  • History or evidence of active central nervous system (CNS) disease
  • Current or recent participation in another experimental drug study
  • Clinically significant cardiovascular disease
  • Active infection requiring parenteral antibiotics
  • Recent major surgical procedure, open biopsy, significant traumatic injury, fine needle aspirations, 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
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment
  • Pregnancy (positive pregnancy test) or breast feeding
  • Serious, non-healing wound, ulcer, or bone fracture
  • Known sensitivity to any of the products administered during the study
  • Any disorder that compromises the ability of the patient to provide written informed consent and/or comply with study procedures
  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: NCT00497497

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Gordon Bray, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00497497     History of Changes
Other Study ID Numbers: APM4187g
Study First Received: July 3, 2007
Last Updated: February 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
CRC
Colon cancer
Avastin
APM4187g

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Bevacizumab
Cetuximab
Irinotecan
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014