Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors

Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors


Hauptsponsor: Roswell Park Cancer Institute

Quelle Roswell Park Cancer Institute
Kurze Zusammenfassung

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.

detaillierte Beschreibung


- 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.

Gesamtstatus Completed
Anfangsdatum August 2001
Fertigstellungstermin June 2009
Primäres Abschlussdatum May 2003
Phase Phase 1
Studientyp Interventional

Interventionsart: Drug

Interventionsname: gemcitabine hydrochloride

Interventionsart: Drug

Interventionsname: irinotecan hydrochloride




- 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



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- At least 12 weeks


- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- AST and ALT no greater than 1.5 times normal

- Bilirubin no greater than 1.5 mg/dL

- No clinically apparent jaundice


- Creatinine no greater than 1.6 mg/dL OR

- Creatinine clearance at least 50 mL/min


- Cardiac function normal

- No uncontrolled heart disease

- No myocardial infarction within the past 3 months

- No congestive heart failure

- No unstable or uncontrolled angina


- 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


Biologic therapy

- Not specified


- No prior gemcitabine

- No prior camptothecin compounds

- Prior irinotecan allowed

- No other concurrent chemotherapy

Endocrine therapy

- Not specified


- See Disease Characteristics

- At least 14 days since prior radiotherapy

- No concurrent radiotherapy


- Not specified


- More than 30 days since prior clinical trial participation

- No other concurrent investigational medications

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Nithya Ramnath, MD Study Chair Roswell Park Cancer Institute
Einrichtung: Roswell Park Cancer Institute
Standort Länder

United States


January 2014

Verantwortliche Partei

Nenne den Titel: Nithya Ramnath, MD

Organisation: Roswell Park Cancer Institute

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Studiendesign Info

Zuweisung: Non-Randomized

Hauptzweck: Treatment

Maskierung: None (Open Label)