AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer

NCT00275028 | Completed Phase 2 Results DMC

• 3 other identifiers: NCI-2013-0003605-170U01CA062490
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well AZD2171 works in treating patients with recurrent ovarian, peritoneal, or fallopian tube cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor

Conditions

Fallopian Tube Cancer; Primary Peritoneal Serous Adenocarcinoma; Recurrent Ovarian Epithelial Cancer; Stage I Ovarian Epithelial Cancer; Stage II Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RESIST) Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started

  Up to 12 months

Secondary Outcomes (1)

• Progression-free Survival

  Up to 2 years

Study Arms (1)

Treatment (cediranib maleate)

EXPERIMENTAL

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: cediranib maleate

Interventions

cediranib maleate DRUG

Given orally

Also known as: AZD2171, Recentin

Treatment (cediranib maleate)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must have histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer
• must have either measurable cancer by RECIST criteria or an elevated CA125
• Subjects must be asymptomatic or minimally symptomatic
• Prior therapy:
• Prior chemotherapy must have included a first-line platinum-based regimen only
• Prior hormonal-based therapy for ovarian, primary peritoneal serous or fallopian tube cancer is acceptable
• Up to two prior lines of chemotherapy in the recurrent setting are allowed
• Toxic side effects related to prior chemotherapy or hormonal therapy must have resolved to less than or equal to grade 1 or to baseline (excluding alopecia), or for peripheral neuropathy to less than or equal to grade 2
• Subjects may begin AZD2171 at least 3 weeks after their last dose of chemotherapy or hormonal therapy
• Life expectancy of greater than 6 months
• ECOG performance status 0-1 (Karnofsky \>= 70%)
• must have lab values within normal institutional limits
• eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of AZD2171 will be determined following review of their case by the Principal Investigator
• Subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible; subjects with stage I or II cancer treated with a curative intent are also eligible with no evidence of recurrent disease
• No evidence of preexisting uncontrolled hypertension; if patient has hypertension, it must be medically controlled

You may not qualify if:

• Patients who have had chemotherapy, radiotherapy, or major surgery within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
• Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 3 weeks; subjects may not have received prior treatment affecting the VEGF pathway; subjects may not have received prior treatment with antibodies that may interfere with CA-125 measurements; subjects may not have received intraperitoneal therapy within the 4 weeks prior to starting AZD2171 and/or the treating physician must confirm the patient has recurrent disease
• Patients may not be receiving any medication that may markedly affect renal function
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171
• Mean QTc \> 500 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome
• Uncontrolled intercurrent illness
• Pregnant women are excluded from this study because AZD2171 is a VEGF inhibitor with known abortifacient effects; breastfeeding should be discontinued if the mother is treated with AZD2171
• Major surgical procedure or medical interference with the peritoneum or pleura within 4 weeks of baseline CA-125 assessments
• Subjects with a history of an active malignancy during the last 3 years except non-melanomatous skin cancer , in situ breast or cervical cancer or stage I or II cancer treated with a curative intent and no active cancer recurrence
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171
• No therapeutic anti-coagulation; prophylaxis against central venous catheter-associated clots is permitted
• A New York Heart Association classification of III or IV
• Conditions requiring concurrent use of drugs or biologics with proarrhythmic potentiate

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

cediranib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Kimberley MacNeill
• Organization: Dana-Farber Cancer Institute

kmacneill@partners.org

617-632-2621

Study Officials

• Ursula Matulonis

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: October 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: January 1, 2011
• Last Updated: November 9, 2015
• Results First Posted: November 9, 2015

Record last verified: 2013-01

Locations

US (1)