Phase I Study of CBP501 and Cisplatin in Patients With Advanced Refractory Solid Tumors

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to find the answers to the following questions:

1. What are the highest doses of CBP501 and cisplatin that can be safely administered as consecutive 2-hours and 1-hour infusions every 21 days?

2. What are the side effects of the combination of CBP501 and cisplatin when given as an infusion every 21 days?

3. What amount of CBP501 and cisplatin are found in the blood at certain times after it is given?

4. Are there any substances in your blood or tumor that can tell us about tumor sensitivity to CBP501 and cisplatin?

5. Will CBP501 given with cisplatin help to treat your cancer?

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CanBas Co. Ltd.
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Signed informed consent obtained prior to initiation of any study-specific procedures.

• Pathologically-confirmed, locally advanced or metastatic solid tumors, refractory to standard therapy.

• Male or female patients aged 18 years or over.

• ECOG Performance Status (PS): 0-1.

• Life expectancy > 3 months.

• Previous anticancer treatment must be discontinued at least 3 weeks prior to first dose of study treatment (6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, with the exception of 8 weeks for bicalutamide).

• Adequate organ function including the following:

• Bone Marrow: absolute neutrophil count (ANC) ³ 1.5 x 109/L, platelet count ³ 100 x 109/L, hemoglobin ³ 9 g/dL

• Hepatic: Bilirubin £ 1.5 x the upper limit of normal (ULN), aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) £ 2.5 x ULN (or ≤ 5 x ULN if liver metastases are present), INR £ 1.5 x ULN

• Renal: Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ³ 70 mL/min (calculated according to the Cockroft and Gault formula)

• Metabolic: serum potassium, calcium and magnesium ³ lower limit of normal (LLN)

• Creatine phosphokinase isoenzymes: CPK-MB, CPK-MM ≤ ULN

• Troponin I serum level within normal values

• Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to the study and 4 months after the last dose of study drug. For the purposes of this study, child-bearing potential is defined as: "All female patients unless they are post-menopausal for at least one year or are surgically sterile".

• Male patients must use a form of barrier contraception approved by the investigator during the study and for 4 months after the last dose of study drug.

• Ability to co-operate with the treatment and follow-up.

Exclusion Criteria:

• Radiation therapy to more than 30% of the bone marrow prior to entry into the study.

• Prior chemotherapy with nitrosoureas or high dose carboplatin (AUC > 6 mg/mL), prior mitomycin C cumulative dose ³ 25 mg/m², prior bone marrow transplant or intensive chemotherapy with stem cell support.

• Presence of any serious concomitant systemic disorders incompatible with the study (e.g. uncontrolled congestive heart failure, active infection, etc.).

• Any previous history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.

• Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance.

• Evidence of peripheral neuropathy > grade 1 according to NCI-CTCAE Version 3.

• Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry.

• Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.

• Known HIV, HBV, HCV infection.

• Active CNS metastasis: patients with a history of CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for > 1 week prior to enrollment.