A Phase II Study of Weekly Docetaxel and Topotecan in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer (Topo Txt)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Carilion Clinic
ClinicalTrials.gov Identifier:
NCT00484666
First received: June 7, 2007
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

Primary objective:

To estimate the overall clinical response rate (CR, PR, SD) of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer.

Secondary objectives:

To access the safety and tolerability of this novel combination chemotherapy regimen of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer

To estimate the progression free survival (PFS) and overall survival (OS) for women with recurrent platinum resistant ovarian or primary peritoneal cancer treated with this weekly docetaxel and weekly topotecan.


Condition Intervention Phase
Ovarian Cancer
Drug: Docetaxel
Drug: Topotecan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Weekly Docetaxel and Topotecan in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Carilion Clinic:

Primary Outcome Measures:
  • To estimate the overall clinical response rate (CR, PR, SD) of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To access the safety and tolerability of this novel combination chemotherapy regimen of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Meds Drug: Docetaxel Drug: Topotecan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients will have had histologically documented ovarian epithelial, fallopian tube or peritoneal cancer.
  • Patients must have received one prior platinum- and paclitaxel based regimen
  • Patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.
  • Patients must not have received radiotherapy.
  • Patients with the following histologic epithelial cell types are eligible:

    • Serous Adenocarcinoma
    • Endometrioid Adenocarcinoma
    • Mucinous Adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell Adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell
    • Malignant Brenner's tumor
    • Adenocarcinoma NOS
  • Patients may have measurable or evaluable disease whereas evaluable disease is defined as new onset pleural effusion, ascites or a rise in CA-125 level >2x institutions upper limit of normal x 2 now sooner than one week apart.
  • Patients could not have more than two previous chemotherapeutic regimens for their advanced ovarian cancer.
  • Patients must be at least 18 years of age
  • Patients must have a serum creatinine < 1.5 mg/dl
  • Patients must have adequate hematologic reserve (ANC > 1500/mm3, hemoglobin ≥ 9.0 gm/dL and platelets > 100,000/mm3)
  • Patients must have adequate hepatocellular function:

    * Total Bilirubin < institutional upper limits of normal (ULN), AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility

  • Patients must have GOG performance status of 0, 1 or 2.
  • Patients must a have signed, approved informed consent form on file.

Exclusion Criteria:

  • Patients with borderline ovarian cancer.
  • Patients with GOG performance status 3 or 4.
  • Patients who have received prior topotecan and/or docetaxel.
  • Patients who have a history of psychiatric illness or other concurrent severe and/or uncontrolled co-morbid medical condition that would preclude study completion (i.e., uncontrolled infection, hypertension, ischemic heart disease, myocardial infarction within 6 months, congestive heart failure).
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer or any evidence of the other cancer(s) present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
  • Patients with a history of severe acute hypersensitivity reaction to medications formulated with polysorbate 80.
  • Patients with baseline peripheral neuropathy ≥ Grade 2.
  • No use of investigational drugs or alternative medicine anticancer therapy within the last 4 weeks of 1st dose of study drug.
  • Pregnant or lactating women with reproductive potential. (All patients enrolled in this study will be postmenopausal or have undergone surgery that includes hysterectomy and oophorectomy that would render them unable to conceive children.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484666

Locations
United States, Virginia
Carilion GYN Oncology Associates
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Carilion Clinic
GlaxoSmithKline
Investigators
Principal Investigator: Dennis R Scribner, JR, MD Carilion Clinic
  More Information

Publications:
Ozols RF, Bundy BN, Fowler J, Clarke-Pearson D, Mannel R, Hartenbach EM, Baergen R. Randomized phase III study of cisplatin/paclitaxel versus carboplatin/paclitaxel in optimal stage III epithelial ovarian cancer: A GOG trial. Proc Am Soc Clinic Onc 1999;18:356a.
Morris RT, Munkarah A, Field J, Baker VV, Drake R, Malone J. Phase II trial of weekly topotecan in patients with potentially platinum sensitive relapsed ovarian and peritoneal cancer. Proc ASCO, 2002; 2512A.
Aapro MS, Pujade-Lauriane E, et al. EORTC Clinical Screening Group: Phase II study of Taxotere in ovarian cancer. Annals of Oncology 5(5):202, abstract 508, 1994.
Vasey PA et. al. Proc Am Soc Clin Onc 2001;20:Abst.1370.
Kuzur ME, Jones S, Willcutt N, et al. The Sarah Cannon Cancer Center/Tennessee Oncology, Nashville, TN; Glaxo Smith Kline, Philadelphia, PA: A phase I trial of weekly topotecan and docetaxel. Proc Am Soc Clin Onc 2003;22:Abst.
Stemmler J, Mair W, Stauch M, et al. Weekly docetaxel with or without corticosteroid premedication as first or second-line treatment in patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol. 2002;21:58a. Abstract 231.
Climent MA, Tabernero J, Albanell J, et al. Preliminary results of a phase II randomized trial of docetaxel (taxotere) as a single agent chemotherapy (CT) administered weekly or 3-weekly in patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol.2002;21:52a. Abstract 205.
McKay C III, Hainsworth J, Burris H III, et al. Weekly docetaxel/gemcitabine in the treatment of elderly patients (pts) with advanced non-small cell lung cancer (NSCLC): a Minnie Pearl Cancer Research Network phase II trial. Proc Am Soc Clin Oncol. 2001;20:260b. Abstract 2793.
Gervais R, Ducoloné AMD, Breton J-L, et al. Multicenter, randomised, phase II trial of docetaxel (Taxotere) 75 mg/m2 q3w versus 40 mg/m2 weekly in patients with pretreated non small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol. 2002;21:310a. Abstract 1238.
Schütte W, Nagel S, Lautenschläger C, et al. Randomized phase III study of weekly versus three-weekly docetaxel as second-line chemotherapy for advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol. 2002;21:308a. Abstract 1228.
Kuzur, ME, Jones S, Willcutt N, et.al. A phase I trial of weekly topotecan and docetaxel. Proc Am Soc Clin Oncol. 2003;22: Abstract 2840.

Responsible Party: Carilion Clinic
ClinicalTrials.gov Identifier: NCT00484666     History of Changes
Other Study ID Numbers: Topo Txt
Study First Received: June 7, 2007
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Carilion Clinic:
recurrent
platinum
resistant
ovarian
primary
peritoneal
cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Topotecan
Docetaxel
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 26, 2014