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A Phase I/II Study of Taxotere, Oxaliplatin, and 5- Fluorouracil


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I/II Study of Taxotere, Oxaliplatin, and 5- Fluorouracil


OBJECTIVES:

Primary

- To establish the maximum tolerated dose of docetaxel when administered with oxaliplatin
and fluorouracil in patients with metastatic or unresectable solid tumors. (Phase I)

- To determine the response rate in patients with metastatic or unresectable
adenocarcinoma of the stomach or gastroesophageal junction treated with this regimen.
(Phase II)

Secondary

- To determine the dose limiting toxicity of this regimen in these patients.

- To evaluate the frequency of CYP3A4, CYP3A5, and MDR polymorphisms and their impact on
toxicity of docetaxel.

- To evaluate the frequency of XRCC1 and ERCC2 polymorphisms and their impact on the
toxicity of oxaliplatin.

- To evaluate the frequency of DPD and TSER polymorphisms and their impact on the
toxicity of fluorouracil.

- To characterize the toxicity profile of this regimen in these patients.

OUTLINE: This is a dose-escalation study of docetaxel.

Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1 and
fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days
for at least 2 courses in the absence of disease progression, symptomatic tumor progression,
or unacceptable toxicity.

Patients undergo blood sample collection periodically for pharmacokinetic and
pharmacogenomic correlative studies. Plasma concentrations of docetaxel are analyzed by
reverse-phase high performance liquid chromatography and tandem mass spectrometry.
Polymorphisms in CYP3A4/5, MDR, and other genes are analyzed by PCR.

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

PROJECTED ACCRUAL: A total of 73 patients (30 for phase I and 43 for phase II) will be
accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic or surgically unresectable solid tumor meeting 1
of the following criteria:

- Any solid tumor (Phase I)

- Adenocarcinoma of the stomach or gastroesophageal junction (Phase II)

- Unidimensionally measurable disease by CT scan or MRI

- No uncontrolled brain metastasis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 8.0 g/dL

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Total bilirubin normal

- Meets 1 of the following criteria:

- Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times ULN

- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

- AP ≤ 5 times ULN AND AST or ALT normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study therapy

- No preexisting neuropathy

- No concurrent uncontrolled illness or other condition that would preclude study
compliance

- No history of severe hypersensitivity reaction to docetaxel or to other drugs
formulated with polysorbate 80

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to agents used in this study

PRIOR CONCURRENT THERAPY:

- Recovered from prior therapy

- More than 4 weeks since prior therapy (Phase I)

- No prior oxaliplatin or taxanes (Phase I)

- More than 4 weeks since prior radiotherapy (Phase I)

- No more than two prior therapies for metastatic disease (Phase I)

- No prior therapy for metastatic disease (Phase II)

- At least 6 months since prior adjuvant therapy (given prior to the occurrence of
metastatic disease) (Phase II)

- Prior fluorouracil and concurrent radiotherapy for palliation of the primary tumor
allowed provided metastatic disease is present outside the radiotherapy field (Phase
II)

- No prior radiotherapy to ≥ 30% of bone marrow

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of docetaxel when given in combination with oxaliplatin and fluorouracil (Phase I)

Outcome Time Frame:

After completion of 1 cycle of therapy (1 cycle = 14 days)

Safety Issue:

Yes

Principal Investigator

Mary Mulcahy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 04I2

NCT ID:

NCT00711243

Start Date:

March 2005

Completion Date:

December 2015

Related Keywords:

  • Gastric Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • adenocarcinoma of the stomach
  • stage III gastric cancer
  • stage IV gastric cancer
  • Stomach Neoplasms

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611