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A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination With Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients With Metastatic Adenocarcinoma of the Pancreas


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Pancreatic Cancer

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Trial Information

A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination With Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients With Metastatic Adenocarcinoma of the Pancreas


Inclusion Criteria:



- The patient has provided signed written informed consent.

- The patient is ≥18 years of age.

- The patient has histologically or cytologically-confirmed pancreatic adenocarcinoma
not amenable to curative treatment with surgery or has documented or suspected
extrapancreatic metastases.

- The patient has either (a) measurable disease as defined by Response Evaluation
Criteria in Solid Tumors Version 1.0 (RECIST) or (b) non-measurable disease with an
elevated baseline CA19-9 level (≥2 x the upper limit of normal [ULN]).

- The patient's Eastern Cooperative Oncology Group (ECOG) performance status is ≤2.

- The patient has adequate hematologic function as defined by an absolute neutrophil
count (ANC) ≥1500/mm3 and a platelet count ≥100,000/mm3 obtained within 2 weeks prior
to the first dose of study medication.

- The patient has adequate hepatic function as defined by a total bilirubin ≤2.0 mg/dL
and transaminases ≤5.0 x ULN obtained within 2 weeks prior to the first dose of study
medication.

- The patient has adequate renal function as defined by serum creatinine ≤2.0 x ULN and
urine dipstick for proteinuria ≤1+ obtained within 2 weeks prior to the first dose of
study medication. If urine dipstick is ≥2+, then a 24-hour urine for protein must
demonstrate < 1000 mg of protein in 24 hours to allow participation in the study.
Urinalysis is also acceptable.

- If the patient is on full-dose anticoagulation therapy (eg, warfarin or low molecular
weight [LMW] heparin), the following criteria must be met:

- The patient has an in-range International Normalized Ratio ([INR]usually between
2 and 3) on a stable dose of oral anticoagulant or be on a stable dose of LMW
heparin

- The patient has no active bleeding or pathological condition that carries a high
risk of bleeding (e.g., tumor involving major vessels or known varices)

- If the patient is not on full-dose anticoagulation therapy, the following criteria
must be met:

- The patient has adequate coagulation function as defined by INR ≤1.5

- The patient has a partial thromboplastin (PTT) ≤ULN obtained within 2 weeks
prior to the first dose of study medication

- If a woman, the patient agrees to use an accepted and effective method of
contraception (hormonal or barrier methods, abstinence) prior to study entry and for
the duration of the study. If a male and sexually active, the patient agrees to use
effective contraception.

- The patient is accessible for treatment and follow-up. Patients enrolled in this
trial must be treated at the participating center.

Exclusion Criteria:

- Endocrine tumors or lymphoma of the pancreas

- Known brain metastases

- Prior therapy with an epidermal growth factor receptor (EGFR) inhibitor or vascular
endothelial growth factor (VEGF) inhibitor

- Prior chemotherapy, hormonal therapy, or radiation therapy for advanced pancreatic
cancer, patients who received chemotherapy and/or radiation therapy in the adjuvant
setting will be eligible as long as the adjuvant therapy was completed >6 months
prior

- Concurrent malignancy other than non-melanomatous skin cancer or carcinoma in situ of
the cervix

- Concurrent treatment with other anti-cancer therapy, including other chemotherapy,
immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy

- Ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations

- History of arterial thrombotic events within 9 months

- History of uncontrolled hypertension (>150/100 mmHg) not on a stable regimen of
anti-hypertensive therapy

- History of significant bleeding events or upper or lower gastrointestinal bleeding
within 9 months

- History of gastrointestinal perforation within 12 months

- Serious non-healing wound ulcer, bone fracture, or major surgical procedure with 28
days

- If a woman, is pregnant or lactating

- An employee of the investigator or study center as well as family members of the
employees

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

Progression-free survival is the time from randomization until the date of progressive disease (PD) or death from any cause whichever is first reported. Patients who die without a reported prior progression were considered to have progresssed on the day of their death. Patients who did not progress were censored at the day of their last tumor assessment.

Outcome Time Frame:

Time from randomization to disease progression or death from any cause (Range: 0 -10 months)

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Chair

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

CP02-0555

NCT ID:

NCT00326911

Start Date:

May 2006

Completion Date:

December 2008

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

ImClone Investigational SiteGreenwich, Connecticut  06830
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteAtlanta, Georgia  30318
ImClone Investigational SiteNew Orleans, Louisiana  70121
ImClone Investigational SiteGreat Falls, Montana  59405
ImClone Investigational SiteGreenville, South Carolina  29605
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SiteLittle Rock, Arkansas  72205
ImClone Investigational SiteWinston-Salem, North Carolina  27103
ImClone Investigational SitePhiladelphia, Pennsylvania  19107