Breast cancer drug shows promise for other cancers
Taxotere® (docetaxel) has exhibited potential for treating head and neck cancer and advanced or metastatic non-small cell lung cancer (NSCLC) in a pair of recently completed Phase II trials. The drug already has FDA approval for use in patients with breast cancer.
A French Phase II study showed promising results for the treatment of patients with advanced or metastatic NSCLC who had already been treated with a cisplatin-based combination chemotherapy. Four out of 15 evaluable patients (26.7%) showed a partial response. In three of the 15 (20%), the tumor stopped growing.
The results are particularly promising because patients with this type of cancer who did not respond to cisplatin treatments had no additional treatment options.
A total of 27 patients were treated on an outpatient basis with 100 mg/m2 of Taxotere, given intravenously for one hour every three weeks. All the patients had received previous cisplatin-based chemotherapy combinations; 57% had cancer that spread to three or more sites in their body; one-third had undergone surgery; and nearly one-half had received radiotherapy.
Side effects, reported as "predictable and manageable," included hair loss, reduced white blood cell count, fluid retention, nausea and vomiting, and skin rash.
A German Phase II study with 43 eligible patients with metastatic disease or recurrent squamos cell carcinoma of the head and neck combined Taxotere and cisplatin. Patients received 100 mg/m2 of Taxotere administered as a one-hour infusion. This was followed by a 75 mg/m2 dose of cisplatin as a three-hour infusion every three weeks.
Of the 33 evaluable patients, four showed a complete response (defined as disappearance of all clinical and radiological signs of cancer). Another 20 demonstrated a partial response (defined as a 50 percent or greater reduction in measurable tumor size).
The side effects in this study, also characterized as "predictable and manageable," included asthenia, diarrhea, hearing loss and neutropenic fever.
Phase II trials typically measure the safety of a drug and associated treatment, according to Doug Arbesfeld, director, product communications, Rohne-Poulenc Rorer. Following Phase I trials, which establish a final dose level for further trials after measuring dose ranging and toxicity, Phase II and III trials ideally "confirm the hopes" of researchers, notes Arbesfeld.
He adds that in many oncology cases a Phase III trial, which is usually simply a larger study than Phase II, overlaps with Phase II. In cases where a Phase II trial is particularly effective in treating a life-threatening disease, a drug manufacturer can approach the FDA and "get on a fast track for approval," says Arbesfeld.
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