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Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Intervention: Sunitinib (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
Susana M. Campos, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

Summary

The purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor.

Clinical Details

Official title: A Phase II Trial of Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Response Rate

Secondary outcome:

16-Week Progression-Free Survival

Progression-Free Survival

Detailed description: This study used a two-stage design to evaluate efficacy of sunitinib based on overall response (OR) defined as complete response (CR) or partial response (PR). The null and alternative OR rate were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=17 patients) achieved PR or better than accrual would proceed to stage two (n=18 patients). There was 42% probability of stopping the trial at stage one if the true OR rate was 5%. With 35 patients, this design had 85% power to detect the 15% difference in OR rates assuming 2-sided type I error rate of 0. 05.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically or cytologically confirmed epithelial ovarian, fallopian tube or

peritoneal cancer

- Recurrent or refractory disease

- Measurable disease, defined by RECIST

- 0 to 3 prior cytotoxic chemotherapy or biologic regimens for metastatic disease

- Adverse events related to prior tumor-specific therapy must have resolved to less

than or equal to grade 1 prior to study entry

- Ability to swallow oral medications

- 18 years of age or older

- ECOG Performance status must be 0-2

- Normal organ and marrow function as outlined in the protocol

Exclusion Criteria:

- Receiving systemic therapy less than 14 days prior to starting sunitinib

- Receiving any other investigational agent

- Received prior sunitinib

- Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain

metastases or leptomeningeal disease as noted on screening CT or MRI scans

- Any of the following within the 6 months prior to study drug administration:

myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.

- Evidence of a bleeding diathesis. Major surgery or NCI CTCA 3. 0 grade 3 or worse

hemorrhage within 4 weeks of starting study treatment

- Ongoing cardiac dysrhythmias of NCI CTCAE version 3. 0 grade > 2

- Pre-existing thyroid abnormality, with thyroid function tests that cannot be

maintained in the normal range with medication

- Prolonged QTc interval on baseline EKG

- Uncontrolled hypertension

- Patients who are taking cytochrome P450 enzyme-inducing antiepileptic drugs,

rifampin, theophylline, ketoconazole, or St. John's wort.

- Psychiatric illness or social situations that wold limit compliance with study

requirements

- Other severe acute or chronic medical or psychiatric condition or laboratory

abnormality that may increase the risk associated with study participation or study drug administration

- Pregnant women

- Clinical or radiographical evidence of a small bowel obstruction

- Poor oral intake

Locations and Contacts

Beth-Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02214, United States

Additional Information

Starting date: September 2008
Last updated: June 3, 2015

Page last updated: August 23, 2015

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