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Dose-finding Study of Satraplatin in Combination With Oral Vinorelbine in Patients With Advanced Solid Tumors

Phase 1
18 Years
75 Years
Open (Enrolling)
Advanced Solid Tumors

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Trial Information

Dose-finding Study of Satraplatin in Combination With Oral Vinorelbine in Patients With Advanced Solid Tumors

Inclusion Criteria:

1. 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.

2. 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

3. Progressive disease (also in terms of tumor markers only, like CA 125 for ovary and
PSA for prostate). No measurable disease is necessary.

4. Age 18-75 years

5. Prior chemotherapy of ≤ 2 lines for advanced disease

6. ECOG Performance Status < 2

7. Life expectancy of at least 3 months

8. The patient or his/her legal representative must be able to read, understand and
provide written evidence of informed consent

9. 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.

10. Male patients that are not surgically sterile must be practicing a medically
acceptable contraceptive regimen while on study treatment

11. 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 Criteria:

1. Other chemotherapy treatment < 4 weeks prior to enrolment

2. Treatment with vinorelbine < 6 months from time of enrolment

3. 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)

4. 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

5. Hypersensitivity or allergic reactions to platinum compounds or vinorelbine

6. Radiotherapy involving > 30% of the active bone marrow

7. Radiotherapy < 4 weeks prior to enrolment

8. Pre-existing peripheral neuropathy > grade 1

9. Pre-existing CTCAE hearing loss or tinnitus ≥ grade 2

10. 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

11. Patients who have not recovered (> grade 1) from the following toxicities of previous
regimens before enrolment: fatigue, mucositis, nausea/vomiting, diarrhoea

12. 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)

13. 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

14. Pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical
situation which could affect oral absorption

15. History of human immunodeficiency (HIV) or acquired immunodeficiency syndrome (AIDS)
related illness

16. Concurrent use of medications that inhibit cytochrome P450 3A4

17. History of bone marrow or major organ transplant

18. Prior high dose treatment with PBSC support

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) based upon study drug related dose limiting toxicities (DLTs)

Outcome Description:

The Maximum Tolerated Dose (MTD) is defined as the dose at which 2 out of 3 to 6 patients experience a DLT.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Cristiana Sessa, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Swiss Group for Clinical Cancer Research


Switzerland: Swissmedic

Study ID:




Start Date:

February 2008

Completion Date:

February 2011

Related Keywords:

  • Advanced Solid Tumors
  • solid tumors
  • oral treatment
  • platinum compound
  • vinca alkaloid
  • drug combination
  • Neoplasms