Carboplatin-Paclitaxel ± Bevacizumab in Advanced (Stage III-IV) or Recurrent Endometrial Cancer

Conditions

• Stage III-IV or Recurrent Endometrial Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  Carboplatin AUC 5+ Paclitaxel 175 mg/mq+Bevacizumab 15 mg/kg q 21 for 6 -8 cycles + Bevacizumab 15 mg/kg
• Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles — DRUG
  Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles

Study Details

Wright et al (Anticancer Res, 2000) reported the results of a retrospective study on 11 patients with advanced/recurrent endometrial cancers. All patients had multi-site disease and were heavily pretreated with a median of 3 prior chemotherapy regimens. All received bevacizumab combination therapy which was well-tolerated. Two patients had partial responses, 3 had stable disease, while 5 patients progressed. One subject was not assessable for response. The median progression-free interval was 5.4 months for the entire cohort and 8.7 months for those who achieved clinical benefit (PR or SD). The authors concluded that Bevacizumab was well-tolerated and displayed promising anti-neoplastic activity in patients with endometrial cancer.The rationale for combining anti-angiogenic agents, including anti-VEGF antibodies, with cytotoxic chemotherapy stems from a number of preclinical studies showing additive and synergistic anti-tumour activity in a number of solid tumour types. By combining VEGF-targeting agents such as bevacizumab with conventional chemotherapies, it is hoped that these agents will act synergistically, thereby enhancing their anti-tumour efficacy and controlling disease progression. The addition of bevacizumab to chemotherapy has been shown to improve PFS and/or OS in a series of large, randomized Phase III clinical trials in a wide range of tumour types, including mCRC, non-squamous NSCLC, metastatic BC (mBC) and mRCC.

Key Dates

First listed

Jan 17, 2013

Start date

Apr 30, 2012

Status verified

Dec 2012

Primary completion

Dec 31, 2017

Completion

Dec 31, 2017

Study Design

Enrollment

108 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Carboplatin-paclitaxel-bevacizumab
  Carboplatin AUC 5+ Paclitaxel 175 mg/mq+Bevacizumab 15 mg/kg q 21 for 6 -8 cycles + Bevacizumab 15 mg/kg every 3 weeks until disease progression
• Active Comparator: carboplatin-paclitaxel
  Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles

Primary Outcome Measure

Progression-free survival [ Time Frame: 3 months ]

Central Contacts

• Catholic University of Sacred Heart .
  +39 0630156279