Combination Chemotherapy in Treating Patients With Metastatic Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003711
First received: November 1, 1999
Last updated: May 29, 2013
Last verified: April 2000
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with pemetrexed disodium and irinotecan in treating patients who have metastatic solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: irinotecan hydrochloride
Drug: pemetrexed disodium
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of LY231514 With Irinotecan Administered Intravenously Every 21 Days in Patients With Metastatic Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1997
Study Completion Date: September 2004
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of LY231514 followed by irinotecan in patients with metastatic cancer. II. Determine the quantitative and qualitative toxicity of LY231514 in combination with irinotecan in these patients. III. Assess plasma pharmacokinetics in these patients treated with this regimen. IV. Document any antitumor activity of this regimen in these patients.

OUTLINE: This is a dose escalation study. Patients receive LY231514 IV over 10 minutes followed by irinotecan IV over 90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression and unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of LY231514 and irinotecan. If escalation of one drug in the combination results in unacceptable dose limiting toxicity (DLT), the drug is not escalated further. Instead, the dose of that drug is decreased to its safe dose, and the second drug is escalated until unacceptable DLT results. If DLT occurs in 2 of up to 6 patients at any level, dose escalation is stopped. The maximum tolerated dose is defined as the highest dose at which fewer than 2 of 6 patients experience DLT during courses 1 or 2.

PROJECTED ACCRUAL: Up to 42 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic solid tumors that are refractory to standard therapies or for which no potentially effective therapy exists No leukemia, lymphoma, or multiple myeloma Measurable or evaluable disease No pleural or peritoneal effusions No symptomatic brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal AST and ALT no greater than 3 times normal (no greater than 5 times normal if liver involvement present) Albumin at least 2.5 g/dL Renal: Creatinine clearance at least 45 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study No active infection No concurrent serious systemic disorders Body surface area no greater than 3.0 m2

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior LY231514 or irinotecan No greater than 6 prior courses of a regimen containing an alkylating agent (except low dose cisplatin) No greater than 4 prior courses of a carboplatin-containing regimen No prior mitomycin No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy (except contraceptives or corticosteroids) Radiotherapy: No prior radiotherapy to 25% or more of the bone marrow No prior radiotherapy to the whole pelvis Recovered from any prior radiotherapy No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since any prior investigational agents No concurrent experimental medications No aspirin or other nonsteroidal antiinflammatory agents for 2 days prior, the day of, and 2 days after the dose of LY231514 (5 days prior to LY231514 for long acting agents such as piroxicam)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003711

Locations
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
San Antonio Cancer Institute
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
San Antonio Cancer Institute
Investigators
Study Chair: Thomas R. Johnson, MD San Antonio Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003711     History of Changes
Other Study ID Numbers: LILLY-H3E-MC-JMAX(a), UTHSC-9675011396, CDR0000066819, SACI-IDD-97-08, NCI-V98-1505
Study First Received: November 1, 1999
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Irinotecan
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014