Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors - Full Text View

Sponsor:	Roswell Park Cancer Institute
Information provided by:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00054288

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 combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine Irinotecan U 101440E Gemcitabine hydrochloride Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Study Start Date:	August 2001
Study Completion Date:	June 2009
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors.
Determine the antitumor activity and toxicity of this regimen in these patients.
Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
Determine the optimal dose and time interval for this regimen in these patients.

OUTLINE: This is an open-label, non-randomized, dose-escalation study of irinotecan.

Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan 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 toxicity.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed advanced solid tumor that is refractory to prior treatment
- Considered incurable with other modalities
Measurable or evaluable disease
- The following are not considered measurable or evaluable:
  - Bone metastases
  - Pleural, pericardial, or peritoneal effusions
  - Irradiated lesions (unless progression is documented after radiotherapy)
- Metastatic disease that has been followed using serum tumor markers allowed
No symptomatic brain metastases
Brain metastases may not be sole site of metastatic disease

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

At least 12 weeks

Hematopoietic

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

AST and ALT no greater than 1.5 times normal
Bilirubin no greater than 1.5 mg/dL
No clinically apparent jaundice

Renal

Creatinine no greater than 1.6 mg/dL OR
Creatinine clearance at least 50 mL/min

Cardiovascular

Cardiac function normal
No uncontrolled heart disease
No myocardial infarction within the past 3 months
No congestive heart failure
No unstable or uncontrolled angina

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No active infection requiring systemic therapy
No uncontrolled seizures
No uncontrolled diabetes mellitus

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior gemcitabine
No prior camptothecin compounds
Prior irinotecan allowed
No other concurrent chemotherapy

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
At least 14 days since prior radiotherapy
No concurrent radiotherapy

Surgery

Not specified

Other

More than 30 days since prior clinical trial participation
No other concurrent investigational medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054288

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Study Chair:

Nithya Ramnath, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Nithya Ramnath, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00054288 History of Changes
Other Study ID Numbers:	CDR0000270343, RPCI-DS-01-18
Study First Received:	February 5, 2003
Last Updated:	March 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms
Gemcitabine
Irinotecan
Camptothecin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012