Status:
UNKNOWN
Satraplatin and Vinorelbine in Advanced Solid Tumors
Lead Sponsor:
Southern Europe New Drug Organization
Collaborating Sponsors:
Agennix
Pierre Fabre Laboratories
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Vinorelbine (NVB) and platinum compounds are anticancer agents with broad spectrum of efficacy, clinically and preclinically proven synergism and only partially overlapping toxicities. Combinations wi...
Eligibility Criteria
Inclusion
- Histologically/ cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective.
- Histological/cytological diagnosis of solid tumors in which treatment with oral vinorelbine and oral platinum compounds(preferentially breast, NSCL, GU or GY tumors) is medically indicated
- Progressive disease (also in terms of tumor markers only, like CA 125 for ovary and PSA for prostate). No measurable disease is necessary.
- Age 18-75 years
- Prior chemotherapy of ≤ 2 lines for advanced disease
- ECOG Performance Status \< 2
- Life expectancy of at least 3 months
- The patient or his/her legal representative must be able to read, understand and provide written evidence of informed consent
- Female patients must not be pregnant or lactating and must be willing to practice contraception. The effects of satraplatin on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation.
- Male patients that are not surgically sterile must be practicing a medically acceptable contraceptive regimen while on study treatment
- Adequate organ function as defined by the following:
- Serum creatinine \< 1.5 mg/dl (\< 132 umol/l)
- ANC \> 1500/microL
- Hb \> 10 g/dl
- Platelet \> 100,000/microL
- Total bilirubin \< ULN for the reference laboratory
- AST and ALT and alkaline phosphatase (AP) must be within the designated range allowing for eligibility.
Exclusion
- Other chemotherapy treatment \< 4 weeks prior to enrolment
- Treatment with vinorelbine \< 6 months from time of enrolment
- Known resistance to platinum chemotherapy containing regimens (resistance is defined as PD while on treatment or a progression free interval \< 6 months after completion of platinum therapy)
- Known resistance to vinca alkaloids, treatment (including continuous infusion). Resistance is defined as PD while on treatment or a progression free interval \< 6 months after completion of therapy
- Hypersensitivity or allergic reactions to platinum compounds or vinorelbine
- Radiotherapy involving \> 30% of the active bone marrow
- Radiotherapy \< 4 weeks prior to enrolment
- Pre-existing peripheral neuropathy \> grade 1
- Pre-existing CTCAE hearing loss or tinnitus ≥ grade 2
- Metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, had a negative imaging study within 4 weeks of study entry, is clinically stable with respect to the tumor at the time of study entry, and is not receiving steroid therapy or taper
- Patients who have not recovered (\> grade 1) from the following toxicities of previous regimens before enrolment: fatigue, mucositis, nausea/vomiting, diarrhoea
- Subject is currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving other investigational agent(s)
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
- Pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption
- History of human immunodeficiency (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
- Concurrent use of medications that inhibit cytochrome P450 3A4
- History of bone marrow or major organ transplant
- Prior high dose treatment with PBSC support
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01220284
Start Date
February 1 2008
End Date
February 1 2011
Last Update
October 13 2010
Active Locations (2)
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1
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Bellinzona, Switzerland, 6500
2
Kantonspital Graubünden
Chur, Switzerland, 7000