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Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers


Phase 1
18 Years
75 Years
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers


OBJECTIVES:

Primary

- Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride,
capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.

Secondary

- Analyze the limiting toxicities according to CTC.

- Analyze the toxicity according to CTC.

- Determine the recommended dose.

- Determine the pharmacokinetic dosages of the three drugs.

- Analyze interactions between the drugs.

OUTLINE: This is a multicenter study.

Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30
minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib
hydrochloride once daily on days 1-28.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Advanced disease

- No standard curative therapy available

- Must have received prior first-line chemotherapy

- No brain metastasis

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- Life expectancy ≥ 8 weeks

- ANC ≥ 1.5 x 10^9/ L

- Platelet count ≥ 130 x 10^9/ L

- Hemoglobin ≥ 10 g/dL

- Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the
presence of liver metastases)

- Bilirubin ≤ 1.5 times ULN

- Creatinine ≤ 130 mmol/L OR creatinine clearance > 30 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No intolerance or hypersensitivity to any of the drugs being tested

- No history of interstitial lung disease

- No history of severe cardiac disease

- No serious uncontrolled infection

- No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or
malabsorption of glucose or galactose syndrome

- Must not be deprived of liberty or under guardianship

- Must not be on probation

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior erlotinib hydrochloride

- No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4

- More than 14 days since participation in another clinical trial

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Clinical or laboratory toxicities as assessed by CTC

Safety Issue:

Yes

Principal Investigator

Eric Francois

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

Unspecified

Study ID:

CDR0000633338

NCT ID:

NCT00885066

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • Pancreatic Neoplasms

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