Lung Cancer Clinical Trial
Official title:
A Phase I Study of NX 211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2, and 3 Every 3 Weeks in Patients With Solid Tumors
Verified date | April 2020 |
Source | Canadian Cancer Trials Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one chemotherapy drug may kill more tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of liposomal lurtotecan plus cisplatin in
treating patients who have advanced or metastatic solid tumors.
Status | Completed |
Enrollment | 14 |
Est. completion date | December 21, 2009 |
Est. primary completion date | September 26, 2002 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced and/or
metastatic solid tumor refractory to standard curative therapy or for which no curative
therapy exists Clinically or radiographically documented disease No tumor marker elevation
as only evidence of disease No untreated brain or meningeal metastases Previously treated
and stable CNS metastases allowed (i.e., no evidence of increasing disease by CT scan for
at least 4 weeks) Recommended phase II dose portion of study: Previously untreated advanced
and/or metastatic disease for which a cisplatin-based regimen is indicated (e.g., non-small
cell lung cancer, small cell lung cancer, ovarian, or head and neck cancer) At least one
measurable lesion at least 20 mm by physical exam or x-ray or at least 10 mm by spiral CT
scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN (5 times ULN if documented liver metastases) Renal: Creatinine no greater than ULN OR Creatinine clearance at least 60 mL/min Other: No greater than grade 1 neuropathy or ototoxicity No other prior or concurrent malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or cervical cancer (for recommended phase II dose) No active or uncontrolled infections No other serious illnesses or medical conditions that would preclude study No known hypersensitivity to systemic liposomal formulation or any drug chemically related to study drug Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy Recovered from prior immunotherapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen (adjuvant and/or metastatic) except for nonmyelosuppressive agents (e.g., signal transduction inhibitors or immunotherapy) At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin and 4 weeks for carboplatin) and recovered At least 1 year since prior high-dose chemotherapy with marrow or stem cell support No prior total cisplatin dose of more than 300 mg/m2 No prior chemotherapy (for recommended phase II dose) Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of bone marrow reserve, except for low-dose nonmyelosuppression Surgery: Not specified Other: At least 4 weeks since other prior experimental drugs or anticancer therapy and recovered No other concurrent investigational or anticancer therapy |
Country | Name | City | State |
---|---|---|---|
Canada | Cancer Care Ontario-Hamilton Regional Cancer Centre | Hamilton | Ontario |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | British Columbia Cancer Agency | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
NCIC Clinical Trials Group |
Canada,
MacKenzie MJ, Hirte HW, Siu LL, Gelmon K, Ptaszynski M, Fisher B, Eisenhauer E. A phase I study of OSI-211 and cisplatin as intravenous infusions given on days 1, 2 and 3 every 3 weeks in patients with solid cancers. Ann Oncol. 2004 Apr;15(4):665-70. — View Citation
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