Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer

Brief summary public domain (ClinicalTrials.gov)

This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: I. To determine the response rate and progression-free survival at 6 months in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. II. To determine the toxicity of the combination of temsirolimus and bevacizumab in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. SECONDARY OBJECTIVES: I. To collect blood and tumor specimens from all patients entered on the trial for possible future analysis. OUTLINE: Patients receive temsirolimus intravenously (IV) on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 years.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression Free Survival Rate [6 months]. Number, proportion of patients (95% Confidence Interval). Endometrial Cohort (n=26): 0.52 (0.35 to 0.77); Ovarian Cohort (n=58): 0.40 (0.29 to 0.55); Hepatocellular Cohort (n=27): 0.71 (0.54 to 0.94); Carcinoid Cohort (n=55): 0.84 (0.75 to 0.95); Islet Cell (Double Agent) Cohort (n=54): 0.85 (0.75 to 0.95); Islet Cell (Bevacizumab-only) Cohort (n=24): 0.87 (0.74 to 1.00).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Tumor Response Rate [Up to 3 years]. Number, proportion of participants (95% Confidence Interval). Endometrial Cohort (n=26): 0.31 (0.14 to 0.52); Ovarian Cohort (n=58): 0.31 (0.20 to 0.45); Hepatocellular Cohort (n=27): 0.19 (0.06 to 0.38); Carcinoid Cohort (n=57): 0.12 (0.05 to 0.24); Islet Cell (Double Agent) Cohort (n=58): 0.40 (0.27 to 0.53); Islet Cell (Bevacizumab-only) Cohort (n=24): 0.17 (0.05 to 0.37).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response [Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years]. Median, months (95% Confidence Interval). Endometrial Cohort (n=8): 25.1 (0 to 35.5); Ovarian Cohort (n=18): 6.4 (3.7 to 10.8); Hepatocellular Cohort (n=5): 6.4 (0 to 11.1); Carcinoid Cohort (n=7): 15.0 (0 to 18.8); Islet Cell (Double Agent) Cohort (n=23): 11.3 (8.8 to 21.2); Islet Cell (Bevacizumab-only) Cohort (n=4): 10.9 (3.7 to 34.1).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Incidence of Adverse Events [Every cycle of treatment, up to 3 years]. Count Of Participants, Participants. Grade 3 Adverse Event: Endometrial Cohort (n=26): 17; Ovarian Cohort (n=58): 32; Hepatocellular Cohort (n=27): 24; Carcinoid Cohort (n=57): 32; Islet Cell (Double Agent) Cohort (n=55): 36; Islet Cell (Bevacizumab-only) Cohort (n=24): 13. Grade 4 Adverse Event: Endometrial Cohort (n=26): 1; Ovarian Cohort (n=58): 6; Hepatocellular Cohort (n=27): 0; Carcinoid Cohort (n=57): 6; Islet Cell (Double Agent) Cohort (n=55): 8; Islet Cell (Bevacizumab-only) Cohort (n=24): 0. Grade 5 Adverse Event: Endometrial Cohort (n=26): 1; Ovarian Cohort (n=58): 0; Hepatocellular Cohort (n=27): 1; Carcinoid Cohort (n=57): 2; Islet Cell (Double Agent) Cohort (n=55): 0; Islet Cell (Bevacizumab-only) Cohort (n=24): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [Time from registration to death, assessed up to 3 years]. Median, months (95% Confidence Interval). Endometrial Cohort (n=26): 11.5 (6.5 to NA) [Too few deaths occurred to estimate an upper 95% CI.]; Ovarian Cohort (n=58): 16.3 (11.1 to 21.9); Hepatocellular Cohort (n=27): 14.8 (9.7 to 18.1); Carcinoid Cohort (n=57): 32.7 (25.2 to 38.3); Islet Cell (Double Agent) Cohort (n=58): 35.0 (14.6 to NA) [Too few deaths occurred to estimate an upper 95% CI.]; Islet Cell (Bevacizumab-only) Cohort (n=24): NA (30.6 to NA) [Too few deaths occurred to estimate a median or an upper 95% CI.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Disease Progression [Time from registration to disease progression, assessed up to 3 years]. Median, months (95% Confidence Interval). Endometrial Cohort (n=26): 6.0 (2.5 to 9.8); Ovarian Cohort (n=58): 5.6 (4.3 to 6.4); Hepatocellular Cohort (n=27): 8.0 (5.8 to 10.9); Carcinoid Cohort (n=55): 15.2 (11.4 to 24.2); Islet Cell (Double Agent) Cohort (n=54): 13.1 (11.2 to 16.6); Islet Cell (Bevacizumab-only) Cohort (n=24): 18.0 (10.6 to 37.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Treatment Failure [Time from study entry to the date patients end treatment, assessed up to 3 years]. Median, months (95% Confidence Interval). Endometrial Cohort (n=26): 3.8 (2.3 to 6.4); Ovarian Cohort (n=58): 4.5 (2.7 to 5.6); Hepatocellular Cohort (n=27): 6.5 (2.3 to 8.0); Carcinoid Cohort (n=55): 5.5 (4.4 to 8.1); Islet Cell (Double Agent) Cohort (n=54): 11.3 (8.6 to 13.3); Islet Cell (Bevacizumab-only) Cohort (n=24): 11.8 (5.8 to 18.0).