Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Retinoid in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III, Phase II | Treatment | Closed | 18 and over | Pharmaceutical / Industry | LIGAND-L1069-20 NCI-V96-1050 |
Objectives
I. Compare the progression-free interval following treatment with moderate-dose LGD1069 vs. high-dose LGD1069 vs. placebo in patients with stage IIIB/IV or recurrent non-small cell lung cancer that is stable or responding following combination chemotherapy with a platinum compound plus a taxane, etoposide, or a vinca alkaloid. II. Evaluate the safety and tolerability of LGD1069 in these patients. III. Document objective antitumor responses to LGD1069 in patients with measurable or evaluable disease. IV. Compare patient survival and quality of life in these three treatment groups.
Entry Criteria
Disease Characteristics:
Histologically confirmed, incurable non-small cell lung cancer in one of the following categories: Stage IIIB with pleural effusion (T4, any N, M0) Stage IV (any T, any N, M1) Recurrent after curative resection or primary radiotherapy Stable or responding disease following prior platinum-based combination chemotherapy No more than 1 prior chemotherapy regimen for advanced disease 4-6 cycles (equivalent to 12-24 weeks) of treatment No more than 21-35 days since completion of chemotherapy No subsequent disease progression No CNS metastases unless radiographically stable or improved after whole brain radiation and with evidence of neurologic improvement or normalization
Prior/Concurrent Therapy:
Biologic therapy: Not specified Chemotherapy: At least 6 months since adjuvant chemotherapy See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: At least 1 month since prior therapeutic retinoids No prior therapeutic retinoids for non-small cell lung cancer At least 1 month since prior investigational agents No concurrent drugs that significantly alter hepatic or renal metabolism unless dose stable No concurrent vitamin A in excess of 15,000 IU/day
Patient Characteristics:
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
At least 3 months
Hematopoietic:
WBC at least 3,000/mm3
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hepatic:
Bilirubin no greater than 1.5 times normal
AST/ALT no greater than 2.5 times normal
PT and PTT normal
Triglycerides (fasting) no greater than 800 mg/dL
Renal:
Creatinine less than 2 times normal OR
Creatinine clearance greater than 40 mL/min
Other:
No serious concurrent medical illness
No second malignancy within 5 years except nonmelanomatous skin cancer
No pregnant or nursing women
Negative pregnancy test required of fertile women within 7 days prior to
entry
Effective contraception (including abstinence) required of fertile patients
for 4 weeks prior to, during, and for at least 3 months after treatment
Expected Enrollment
A total of 90 patients will be entered in the Phase II portion of this multicenter study.
Outline
This is a randomized, double-blind study. Patients are stratified by participating institution. Patients are randomly assigned to receive daily oral treatment with high-dose LGD1069, moderate-dose LGD1069, or placebo. Patients in the placebo group are evenly divided to receive approximately 7 or 14 capsules per day. Treatment in all groups continues until disease progression or unacceptable toxicity intervenes. Upon disease progression, patients may receive alternative therapy at the investigator's discretion. No concurrent radiotherapy, hormonal therapy (including progestational agents for appetite stimulation), chemotherapy, immunotherapy, or investigational therapies. Chronic low-dose replacement hormone therapy or low-dose corticosteroids for noncancer-related conditions are allowed. Patients are followed every 2 weeks for 1 month, then every 4 weeks during treatment, at 4 weeks after the last dose, then for survival.
Trial Lead Organizations
Ligand Pharmaceuticals, Incorporated
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| John Tucker, Protocol chair | |
| |
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Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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