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Twenty-four evaluable patients with advanced or recurrent epithelial ovarian carcinoma who progressed on platinum-containing combination chemotherapy were treated with medroxyprogesterone acetate (C.T. Provera) 50 mg orally three times a day until progression of disease. One patient had a partial response (4.2%), 9 patients had stable disease (37.5%), and 14 (58.3%) had increasing disease. The 95% upper confidence limit for response is less than or equal to 18.3%. There was no toxicity associated with its use. C.T. Provera has limited activity in patients with epithelial ovarian cancer who have failed combination chemotherapy.

In this Phase I study, thirteen women with advanced cervix cancer were treated with mitolactol (dibromodulcitol) plus cisplatin to determine a maximum tolerable dose schedule. Response was not an objective of this study, but four partial responses were seen in nine patients with measurable lesions. In general, the therapy was well tolerated, but of the ten patients treated at the first dose level (cisplatin 50 mg/m2 intravenously on day 1 plus mitolactol 180 mg/m2 orally on days 2-6 every 3-4 weeks), 5 required de-escalations and 8 required delays because of toxicity. All three patients treated with cisplatin plus a higher dose of mitolactol (270 mg/m2 x 5) required dose reductions and delays for hematologic toxicity. The first dose level appears tolerable by patients with, and promising in treating, advanced cervix cancer.

Thirty-three patients with advanced or metastatic endometrial carcinoma were entered in a Phase II trial utilizing methotrexate, 40 mg/m2 intravenously on a weekly basis. Almost all patients had prior total abdominal hysterectomy and almost two-thirds prior pelvic irradiation. No patient had prior chemotherapy. There was one complete and one partial response, for a complete and partial response rate of 6% (95% confidence intervals for a response of 1.7 to 19.6%). Toxicity was mild, with major adverse effects being nausea and vomiting and myelosuppression. One death may have been drug related. Methotrexate displays minimal clinical activity in patients with advanced or recurrent endometrial carcinoma who have received no prior chemotherapy.

Twenty-six evaluable patients with advanced or recurrent squamous cell carcinoma of the uterine cervix were treated with mitoxantrone at a dosage of 12 mg/m2 every 3 weeks. Twenty-five of 26 patients had had prior irradiation and 24 prior chemotherapy. There were two partial responses, one in a patient with pelvic recurrence and another in a patient with a right upper quadrant mass. Progression-free intervals for these two patients were 5.1 and 4.6 months, respectively. Toxicity was moderate and consisted mainly of leukopenia. No septic or bleeding complications were observed. Mitoxantrone is minimally active in patients with advanced cervical cancer who have been previously treated.

Clinical records of 371 women with carcinoma of the cervix, Stage IB, treated in the decade 1969-1979 were reviewed. Cancer recurred in 67 women (18.1%). A group of 171 patients treated by radiation, including 25 who were surgically staged prior to treatment, was compared to 200 patients treated by radical abdominal hysterectomy and pelvic node dissection, including 35 who had postoperative whole pelvis radiation. A multifactorial analysis included time to recurrence, site of recurrence, treatment for recurrence, and survival after recurrence. Pathology review and clinicopathological correlation included tumor configuration, histologic type, size of tumor in greatest dimension, and rate of node metastases in patients undergoing either radical hysterectomy or surgical staging procedures. Lesion size was found to be the most accurate predictor of disease-free survival; this was true whether the patient was treated by surgery or radiation and was not significantly affected by the tumor histology. Nodal metastases were associated with increasing size of lesions and predicted high recurrence rates. Node metastasis rates were not affected by the histology of the tumor.