Status:
COMPLETED
Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Small Cell Lung Cancer
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A multi-center, open-label, two-arm, dose-escalation study to establish the safety, tolerability, MTD, and schedule of TLI administered intravenously as a 30 minute infusion in adult subjects with adv...
Detailed Description
The study will utilize an accelerated design with small initial cohort sizes that allow fewer subjects to be enrolled at sub-therapeutic doses such as the very low starting doses in both arms of the s...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Histologically or cytologically confirmed advanced solid tumor that has relapsed, is refractory to standard treatment, or for whom there is no standard therapy available.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Normal organ and marrow function as defined below within 14 days of study entry
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥100 x 109/L
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN), or 5 x ULN for subjects with liver metastases
- Serum creatinine ≤ 1.5 x ULN or calculated estimated creatinine clearance ≥ 50 mL/min/1.73m2 for subjects with creatinine levels above institutional normal based on the Cockcroft and Gault formula.
- Never received prior TLI or topotecan HCl (Hycamtin®)
- At least 4 weeks must have elapsed from the last dose of chemotherapy.
- Life expectancy ≥ 3 months
- Women of childbearing potential must have a negative urine or blood pregnancy test within 7 days prior to initiation of treatment.
- If female, subject is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (e.g., hormonal contraceptive, intra-uterine device (IUD), diaphragm with spermicide, condom with spermicide or abstinence) from the screening visit through the duration of study participation.
- If male, subject agrees to use an acceptable barrier method for contraception from the screening visit though the duration of study participation.
- Before enrollment, the subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign a written informed consent according to ICH/GCP, and national/local regulations.
Exclusion
- Use of any investigational drugs, biologics, or devices within 28 days prior to study treatment or planned use during the course of the study.
- Primary tumors of central nervous system (CNS). Symptomatic brain metastases (unless subject is stable without requirement of steroids and/or antiseizure medications for at least three months) or leptomeningeal tumor involvement. Imaging studies are not required to rule this out unless there is a clinical suspicion of CNS disease.
- Prior chemotherapy or radiotherapy within 4 weeks of Day 1 of study (6 weeks for nitrosureas or mitomycin C).
- Planned concurrent systemic therapy (cytotoxic and/or cytostatic) and/or radiotherapy during study treatment.
- Less than 4 weeks have elapsed from the time of major surgery.
- Subjects with a history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to TLI, including known allergies to the ingredients comprising the liposome (e.g., cholesterol and/or sphingomyelin), which in the Investigator's opinion may put the subject at risk for significant reaction to the study drug.
- Subjects who are pregnant or lactating.
- Subjects known to be positive for human immunodeficiency virus (HIV), hepatitis C antibody, or hepatitis B surface antigen.
- Prophylactic hematologic growth factors administered ≤ 2 weeks prior to start of treatment with TLI (excluding darbepoetin alfa and epoetin alfa).
- Active infection or any serious underlying medical condition, which would impair the ability of the subject to receive protocol treatment.
Key Trial Info
Start Date :
November 10 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00765973
Start Date
November 10 2008
End Date
June 30 2010
Last Update
November 13 2020
Active Locations (2)
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1
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States, 48201
2
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229