Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer (UCDCC#211)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00810719
First received: December 17, 2008
Last updated: August 18, 2014
Last verified: August 2014

December 17, 2008
August 18, 2014
April 2009
January 2013   (final data collection date for primary outcome measure)
Response rate (partial response or complete response) and duration of response [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Response rate (partial response or complete response) and duration of response [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00810719 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Patients will be followed for survival/progression every three months until documented progression, death or study termination. If a patient is still alive, survival time is censored at the time of last follow-up. ] [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer
Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer (OSI 4132s)

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib works in treating patients with metastatic or recurrent pancreatic cancer.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral erlotinib hydrochloride on days 2-5, 9-12, and 16-26. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Archived tumor tissue samples are analyzed for the expression of EGFR, HER3, HER2, downstream signaling molecules, and other molecular markers by immunohistochemistry and RT-PCR. The presence of aberrant gene copy numbers (amplification and polysomy) for EGFR, HER3, and HER2 are determined by FISH. Blood samples are collected at baseline and periodically during study for polymorphism analysis and correlative molecular analysis of surrogate endpoint biomarkers.

After completion of study therapy, patients are followed every 3 months.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: Erlotinib
    Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.
    Other Name: Tarceva
  • Drug: gemcitabine
    The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
    Other Name: Gemzar
Experimental: Gemcitabine and Erlotinib
The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.
Interventions:
  • Drug: Erlotinib
  • Drug: gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced, metastatic or recurrent pancreatic carcinoma
  • Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
  • No prior chemotherapy for metastatic or recurrent disease is allowed. Prior adjuvant chemotherapy is allowed provided that patients did not receive gemcitabine and the chemotherapy was completed > six months prior to initiation of study therapy. Prior erlotinib therapy is not allowed
  • Available tumor specimen that was obtained at the time of diagnosis and/or prior to study entry is highly encouraged
  • Age ≥ 18 years
  • Life expectancy greater than 3 months
  • Zubrod performance status ≤ 2
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes ≥ 3,000/μL
  • absolute neutrophil count ≥ 1,500/ μL
  • platelets ≥ 100,000/ μL
  • total bilirubin ≤ 1.5 X institutional upper limit of normal
  • AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal, unless the liver is involved with tumor, in which case the AST/ALT must be ≤ 5 X institutional upper limit of normal
  • creatinine clearance ≥ 50 mL/min/1.73 m2, as measured by 24hour collection OR
  • creatinine ≤ 1.5 X institutional upper limit of normal
  • The effects of erlotinib and gemcitabine on the developing human fetus at the recommended therapeutic doses are unknown. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or gemcitabine.
  • Secondary primary malignancy. Concurrent or history of another malignancy < 5 years.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because erlotinib and gemcitabine have the potential for teratogenic or abortifacient effects. Breastfeeding should be discontinued if the mother is treated with study drugs.
  • Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00810719
CDR0000629891, P30CA093373
Yes
University of California, Davis
University of California, Davis
National Cancer Institute (NCI)
Principal Investigator: Primo N. Lara, MD University of California, Davis
University of California, Davis
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP