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Irinotecan Plus Raltitrexed in Treating Patients With Refractory Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00003109
First received: November 1, 1999
Last updated: April 16, 2013
Last verified: April 2013
  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 irinotecan plus raltitrexed in treating patients who have refractory solid tumors that have not responded to previous therapy.


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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Pharmacokinetic and Pharmacodynamic Trial of Irinotecan in Combination With Tomudex in Patients With Refractory Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Enrollment: 39
Study Start Date: December 1997
Study Completion Date: January 2001
Primary Completion Date: October 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan in combination with raltitrexed in patients with refractory solid tumors. II. Describe and quantify the toxic effects of this combination treatment regimen in a minimally pretreated patient population. III. Determine the pharmacokinetics of this combination treatment regimen. IV. Document any antitumor activity of this combination treatment regimen in this patient population.

OUTLINE: This is a dose escalation study of irinotecan and raltitrexed. Patients receive irinotecan IV over 90 minutes on days 1 and 8 followed by raltitrexed IV over 15 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of irinotecan and raltitrexed until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Additional cohorts receive raltitrexed on day 2 rather than day 1 near the final dose levels of the combination drugs.

PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study within 1 year.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically proven malignant solid tumor that has failed prior conventional chemotherapy or for which no established therapy exists Recurrent or metastatic gastrointestinal adenocarcinoma with no prior therapy eligible No evidence of CNS metastases (brain or leptomeningeal disease)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL SGOT and SGPT less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 3 times ULN (5 times ULN for metastatic disease) Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No congestive heart failure Other: No uncontrolled diabetes Not pregnant or nursing Negative pregnancy test No other serious medical illness (e.g. clinically active infectious process) No psychiatric illness precluding study No ascites or pleural effusion

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No more than 1 prior adjuvant chemotherapy regimen No more than 1 prior chemotherapy regimen for recurrent or metastatic disease No prior irinotecan or raltitrexed At least 8 weeks since prior nitrosourea or mitomycin and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Prior radiotherapy limited to no greater than 25% of bone marrow Surgery: Not specified

  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: NCT00003109

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Neal J. Meropol, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00003109     History of Changes
Other Study ID Numbers: CDR0000065851, P30CA006927, FCCC-96116, NCI-T96-0113
Study First Received: November 1, 1999
Last Updated: April 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Irinotecan
Raltitrexed
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 November 25, 2014