(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma

NCT01936974 | Terminated Phase 2 Results

• 1 other identifier: 13-27
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma

Conditions

Ovarian Carcinoma; Fallopian Tube Carcinoma; Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Evaluate progression-free survival between the two regimens.

  One Year

Study Arms (2)

Platinum, Gemcitabine and Bevacizumab

EXPERIMENTAL

Platinum: 1. Carboplatin\* on day 1 \*If a patient is allergic to carboplatin, then give 2. Cisplatin\*\* on day 1 \*\*If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1 Gemcitabine on day 1 only Bevacizumab on day 1

Drug: Gemcitabine; Drug: Bevacizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Oxaliplatin

Gemcitabine and Bevacizumab

ACTIVE COMPARATOR

Gemcitabine on days 1 and 8 Bevacizumab on day 1

Drug: Gemcitabine; Drug: Bevacizumab

Interventions

Gemcitabine DRUG

Patient to receive gemzar

Also known as: Gemzar

Gemcitabine and Bevacizumab; Platinum, Gemcitabine and Bevacizumab

Bevacizumab DRUG

Patient to receive avastin

Also known as: Avastin

Gemcitabine and Bevacizumab; Platinum, Gemcitabine and Bevacizumab

Carboplatin DRUG

Patient to receive carboplatin

Also known as: Paraplatin

Platinum, Gemcitabine and Bevacizumab

Cisplatin DRUG

Patient to receive cisplatin

Also known as: Platinol

Platinum, Gemcitabine and Bevacizumab

Oxaliplatin DRUG

Patient to receive Oxaliplatin

Also known as: Eloxatin

Platinum, Gemcitabine and Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years of age with histologically confirmed, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
• Disease progression during or within 6 months of previous platinum-based chemotherapy including the following 4 categories:
• Primary platinum-refractory: Previously untreated patients who do not achieve at least a partial response to platinum-based chemotherapy
• Primary platinum-resistant: Previously untreated patients who have achieved at least a partial response to platinum-based chemotherapy but experience a relapse within a period of 6 months of its conclusion
• Secondary platinum-refractory: Previously treated patients have a relapse 6 months after the conclusion of chemotherapy, but fail to achieve at least a partial response
• Secondary platinum-resistant: Previously treated patients have a relapse 6 months after the conclusion of chemotherapy, achieve at least a partial response with platinum-based therapy as 2nd-line therapy, but experience relapse within 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy \>3 months.
• Absolute neutrophil count \> 1500 mm\^3, platelet count ≥ 100×10\^9 L, hemoglobin ≥ 8.5 g/dL
• Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
• No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
• At least three (3) weeks from prior chemotherapy

You may not qualify if:

• Inadequate renal function with a calculated creatinine clearance less than 51 mL/min
• Uncontrolled cardiac disease, congestive heart failure, angina, or hypertension
• Myocardial infarction or unstable angina within 2 months of treatment
• Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol)
• Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks, pulmonary embolism within the past 6 months
• Bleeding diathesis or significant coagulopathy
• Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug
• Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug
• History of fistula, GI perforation, or intrabdominal abscess
• Serious non-healing wound, ulcer, or bone fracture
• clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition
• Known CNS disease except for treated brain metastasis
• Known platinum drug allergy
• Prior treatment with Platinum + Gemcitabine + Avastin, Gemcitabine + Avastin or Gemcitabine alone
• Prior treatment with more than three (3) lines of chemotherapy including adjuvant chemotherapy

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Gemcitabine; Bevacizumab; Carboplatin; Cisplatin; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Jessica Coats, RN
• Organization: CTCA

jessica.coats@ctca-hope.com

6232073899

Study Officials

• Jordan Waypa, FNP

  Western Regional Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 20, 2018
• Results First Posted: October 25, 2017

Record last verified: 2018-01

Locations

US (1)