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A Two-Part Phase I Study of the Addition of Oxaliplatin to Gemcitabine, and Then Erlotinib Plus Oxaliplatin to Gemcitabine as Radiosensitizers for Pancreatic and Biliary Adenocarcinoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Pancreatic Cancer

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Trial Information

A Two-Part Phase I Study of the Addition of Oxaliplatin to Gemcitabine, and Then Erlotinib Plus Oxaliplatin to Gemcitabine as Radiosensitizers for Pancreatic and Biliary Adenocarcinoma


OBJECTIVES:

- Determine the maximum tolerated dose (MTD) of oxaliplatin and gemcitabine hydrochloride
when combined with radiotherapy in patients with unresectable and/or metastatic
pancreatic or biliary tract adenocarcinoma. (Part 1)

- Determine the MTD of erlotinib hydrochloride and gemcitabine hydrochloride when
combined with oxaliplatin at the MTD and radiotherapy in these patients. (Part 2)

OUTLINE: This is a multicenter, nonrandomized, parallel group, uncontrolled, open-label,
dose-escalation study of gemcitabine hydrochloride, oxaliplatin, and erlotinib
hydrochloride.

- Part 1: Patients receive gemcitabine hydrochloride IV over 30-60 minutes and
oxaliplatin IV on day 1. Patients also undergo external beam radiotherapy (EBRT) once
daily on days 1-5. Treatment repeats every 7 days for up to 6 courses.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and
oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
(DLT). Up to 10 patients are treated at the MTD.

- Part 2: Patients receive gemcitabine hydrochloride, oxaliplatin*, and EBRT as in part
1. Patients also receive oral erlotinib hydrochloride once daily on days 1-5. Treatment
repeats every 7 days for up to 6 courses.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and erlotinib
hydrochloride until the MTD is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience DLT. Up to 10 patients are treated at the MTD.

NOTE: *Patients receive oxaliplatin at the MTD determined in part 1.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Biopsy confirmed diagnosis of any of the following:

- Pancreatic carcinoma

- Ampullary carcinoma

- Biliary tract (gallbladder or bile duct) carcinoma

- Unresectable and/or biopsy-proven metastatic disease

- Suitable for bimodality therapy, as determined by a medical oncologist and radiation
oncologist

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy > 2 months

- ANC > 1,500/mm³

- Platelet count > 100,000/mm³

- Creatinine < 1.5 mg/dL

- Total bilirubin < 2 times upper limit of normal (ULN)

- AST < 3 times ULN (< 5 times ULN if liver metastases are present)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known hypersensitivity to platinum agent or gemcitabine hydrochloride

- No serious medical or psychiatric illnesses that would preclude giving informed
consent

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy to the upper abdomen

- More than 3 weeks since prior chemotherapy

- No prior erlotinib hydrochloride

- At least 5 days since prior and no concurrent CYP3A4 inducer/inhibitor

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of oxaliplatin and gemcitabine hydrochloride (Part 1)

Outcome Description:

The MTC of Oxaliplatin and gemcitabine is defined as the combination for which the rate of toxicities that cause dose reductions plus twice the rate of dsoe limiting toxicity (DLT) is equal to 0.5

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Bert H. O'Neil, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

LCCC 0405

NCT ID:

NCT00266097

Start Date:

August 2004

Completion Date:

September 2011

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Pancreatic Cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • unresectable extrahepatic bile duct cancer
  • unresectable gallbladder cancer
  • adenocarcinoma of the extrahepatic bile duct
  • adenocarcinoma of the gallbladder
  • adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • recurrent extrahepatic bile duct cancer
  • recurrent gallbladder cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Biliary Tract Neoplasms

Name

Location
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570