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A Phase I Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Solid Tumor

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Trial Information

A Phase I Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer


OBJECTIVES:

Primary

- Determine the maximum tolerated dose and the recommended phase II dose of pemetrexed
disodium in combination with oxaliplatin in patients with metastatic solid tumors or
lymphoma.

Secondary

- Determine the quantitative and qualitative toxicities of this regimen in these
patients.

- Determine, preliminarily, the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive pemetrexed disodium IV over 10 minutes and oxaliplatin IV over 2 hours on
day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable
toxicity.

Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium 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. Once
the MTD is determined, the recommended phase II dose will be identified.

After completion of study treatment, patients are followed at 30 days and then periodically
thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.


Inclusion Criteria:



- Pathologic or cytologic diagnosis of solid tumors or lymphoma

- Metastatic disease

- No curative or effective therapy exists

- Measurable or nonmeasurable disease

- No clinically relevant third-space fluid collections

- Fluid collections must be drained before study enrollment

- No leukemia

- No CNS metastases

Exclusion Criteria:

- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

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

- AST and ALT ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement)

- Creatinine clearance ≥ 45 mL/min

- Not pregnant or nursing

- Negative pregnancy test

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

- No active infection or other serious illness that would preclude study participation

- No weight loss ≥ 10% within the past 6 weeks

- No peripheral neuropathy (e.g., diabetic neuropathy) ≥ CTC grade 1

- Must be able to take concurrent vitamin B12 and folic acid

PRIOR CONCURRENT THERAPY:

- No more than 1 prior chemotherapy regimen for metastatic disease

- More than 12 months since prior adjuvant therapy

- More than 30 days since prior drug that has not received regulatory approval

- More than 30 days since prior radiation therapy and recovered (alopecia allowed)

- Prior standard postoperative adjuvant radiation therapy for rectal cancer allowed

- No prior radiation therapy to ≥ 25% of bone marrow

- No prior oxaliplatin or pemetrexed disodium

- No NSAIDs or acetylsalicylic acid 2 days before (5 days for long-acting agents [e.g.,
piroxicam]), during, and for 2 days after each dose of pemetrexed disodium

- No concurrent nonpalliative radiation therapy or surgery for cancer

- No concurrent hormonal cancer therapy (except medroxyprogesterone)

- No other concurrent experimental medications (except thymidine)

- No other concurrent chemotherapy or immunotherapy

- No other concurrent anticancer therapy

- Concurrent palliative radiation therapy allowed for small areas of painful metastasis
that cannot be managed adequately by systemic or local analgesics

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:

Yes

Principal Investigator

Mace L. Rothenberg, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC PHI0367

NCT ID:

NCT00470405

Start Date:

May 2004

Completion Date:

November 2007

Related Keywords:

  • Lymphoma
  • Solid Tumor
  • adult solid tumor
  • unspecified adult solid tumor, protocol specific
  • stage IV adult Hodgkin lymphoma
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • cutaneous B-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • adult nasal type extranodal NK/T-cell lymphoma
  • adult grade III lymphomatoid granulomatosis
  • Waldenstrom macroglobulinemia
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • nodal marginal zone B-cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • splenic marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic
  • Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838