Phase II/III Randomized Study of High-Dose vs Moderate-Dose LGD1069 vs Placebo in Advanced non-Small Cell Lung Cancer (Summary Last Modified 08/98)
Retinoid in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer
Basic Trial Information
|Phase III, Phase II||Treatment||Closed||18 and over||Pharmaceutical / Industry||LIGAND-L1069-20|
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.
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
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
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
A total of 90 patients will be entered in the Phase II portion of this multicenter study.
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 Contact Information
Trial Lead Organizations
Ligand Pharmaceuticals, Incorporated
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.