Randomized Phase II Trial of Carboplatin and Paclitaxel with or without Lonafarnib in First-Line Treatment of Epithelial Ovarian Cancer Stage IIB-IV

Randomized Phase II Trial of Carboplatin and Paclitaxel with or without Lonafarnib in First-Line Treatment of Epithelial Ovarian Cancer Stage IIB-IV: Publication year: 2012

Source: Gynecologic Oncology


Objectives This study evaluates whether a molecular targeted therapy with the farnesyl transferase inhibitor lonafarnib added to standard chemotherapy in first-line treatment of advanced ovarian cancer (OC) could improve progression-free (PFS) and overall survival (OS).

Patients and Methods We performed a prospective randomized phase II study to compare standard therapy carboplatin (C; AUC 5) and paclitaxel (T; 175mg/m2) in primary advanced OC with or without lonafarnib (L). Lonafarnib was given in a dose of 100mg orally twice a day during chemotherapy and was increased afterwards to 200mg up to six months as a maintenance therapy.

Results 105 patients were recruited( 53 patients were randomised to receive LTC, 52 to TC). Hematologic toxicity was similar in both arms. Grade 3 and 4 non-hematological toxicity, occurred significantly more often with LTC (23% versus 4%, p=0.005) and was associated with a higher dropout rate. PFS and OS were not significantly different among both arms. The LTC arm showed inferiority in the stratum with residual tumor of more than 1cm:.....

Conclusion The addition of lonafarnib did not improve PFS or OS. Patients with a residual tumor of more than 1cm had significantly shorter PFS and OS. Incorporation of lonafarnib into future studies for primary therapy of OC is not recommended.

Phase 2 Study Update of Selumetinib for Ovarian Cancer - MPR

Blogger's Note: more info req'd eg. side effects....

Phase 2 Study Update of Selumetinib for Ovarian Cancer - MPR

Array BioPharma announced results of a Phase 2 trial of selumetinib in women with recurrent low-grade serous ovarian or peritoneal cancer.

In the trial, 52 women each received 100mg doses of selumetinib orally twice daily in four-week cycles until disease progression or toxicity. The median number of cycles received was 4.5; 33% underwent ≥12 cycles. Prior to the trial, 58% of the patients in the trial had received three or more rounds of chemotherapy.

A disease control rate, defined as either complete or partial response or progression-free survival or progression-free survival of greater than 6 months, occurred in 81% of patients. Eight patients had complete (1) or partial (7) responses, and 34 (63%) had progression-free survival of >6 months. The median survival rate without cancer progression was 11 months.

Selumetinib is an anti-cancer drug in Phase 2 development in a range of tumors. It is a small molecule MEK inhibitor that targets a key position in the Ras-Raf-MEK-ERK signaling pathway. MEK has been shown to be frequently activated in cancer, in particular in tumors that have mutations in the RAS and RAF pathways.

For more information call (877) MED-CHEM or visit www.arraybiopharma.com

abstract: Predictive value of serum CA-125 levels in patients with persistent or recurrent epithelial ovarian cancer or peritoneal cancer treated with Bevacizumab (Avastin) Gynecologic Oncology Group phase II trial

Purpose

To compare two methods of determining therapeutic response and disease progression — modified Gynecologic Cancer Intergroup (GCIG) criteria based on CA-125 and Radiographic Evaluation Criteria in Solid Tumors (RECIST), in a phase II trial of bevacizumab for patients with recurrent or persistent epithelial ovarian and peritoneal carcinoma.

Results

Sixty-two patients were evaluable by RECIST, 59 for progression by CA-125, and 45 for response by CA-125..........

Conclusions

In this study, disease assessment by RECIST and CA-125 appears to correlate in general. However, approximately 10% of patients might demonstrate progression earlier by CA-125.

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Highlights

► CA125-defined response and progression were assessed for women with recurrent ovarian cancer.
► CA125 and RECIST-defined response and progression correlated in most cases, but CA125 progression significantly preceded RECIST in 8 cases.
► CA125-defined response to bevacizumab was associated with a statistically significant correlation with overall survival.