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)

NCT00497497 | Completed Phase 1

• 1 other identifier: APM4187g
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

CRC; Colon cancer; Avastin; APM4187g

Outcome Measures

Primary Outcomes (1)

• Incidence and nature of dose-limiting toxicities

  Through study completion or early study discontinuation

Secondary Outcomes (3)

• Incidence, nature, and severity of adverse events

  Through study completion or early study discontinuation

• Change in vital signs

  Through study completion or early study discontinuation

• Incidence and severity of infusion reactions

  Through study completion or early study discontinuation

Study Arms (2)

1

EXPERIMENTAL

Drug: cetuximab; Drug: irinotecan; Drug: PRO95780

2

EXPERIMENTAL

Drug: bevacizumab; Drug: FOLFIRI regimen; Drug: PRO95780

Interventions

bevacizumab DRUG

(Only for patients not previously treated with bevacizumab) Intravenous repeating dose

2

cetuximab DRUG

Intravenous repeating dose

1

FOLFIRI regimen DRUG

Intravenous repeating dose

2

irinotecan DRUG

Intravenous repeating dose

1

PRO95780 DRUG

Intravenous repeating dose

1; 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Bevacizumab; Cetuximab; Irinotecan; drozitumab

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; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Gordon Bray, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 6, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 19, 2017

Record last verified: 2017-05