Pemetrexed and Oxaliplatin in Treating Patients With Metastatic Solid Tumors or Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470405
• Other study ID #: VICC PHI0367
• Secondary ID: VU-VICC-PHI-0367
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2007
• Last updated: April 14, 2011
• Start date: May 2004
• Est. completion date: November 2007

Study information

• Verified date: April 2011
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed given together with oxaliplatin in treating patients with metastatic solid tumors or lymphoma.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Solid Tumor

Intervention

Drug:
• oxaliplatin
75-100 mg/m2 iv infusion Approximately 2 hours beginning approximately 30 minutes after the end of ALIMTA infusion on Day 1 of a 14-days cycle
• pemetrexed disodium
a novel antifolate with multiple targets.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stover DG, Lockhart AC, Berlin JD, Chan E, Sandler AB, Sosman JA, Middlebrook V, Nicol S, Rothenberg ML. Phase I trial of pemetrexed plus oxaliplatin administered every other week in patients with metastatic cancer. Invest New Drugs. 2008 Aug;26(4):339-45 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose			Yes
Primary	Recommended phase II dose			Yes
Secondary	Toxicity			Yes
Secondary	Efficacy			No