Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
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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 1 |
| 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 |
| Study Start Date: | August 2001 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
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 |
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| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Study Chair: | Nithya Ramnath, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
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 May 16, 2013