Safety Study Involving Oxaliplatin With Docetaxel for Recurrent Ovarian,Primary Peritoneal, and Fallopian Tube Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Robert Edwards, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00692900
First received: June 4, 2008
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine the safest and maximum tolerated dosing regimens for intraperitoneal oxaliplatin with intravenous docetaxel and intravenous oxaliplatin with intraperitoneal docetaxel for recurrent ovarian, primary peritoneal, or fallopian tube cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Drug: intravenous docetaxel with intraperitoneal oxaliplatin
Drug: intravenous oxaliplatin with intraperitoneal docetaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Dose-Escalation Parallel Studies of Intraperitoneal Oxaliplatin With Intravenous Docetaxel and Intravenous Oxaliplatin With Intraperitoneal Docetaxel in Platinum-Sensitive or Platinum-Resistant Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To determine the safest and maximum tolerated dose regimen for IV oxaliplatin with intraperitoneal docetaxel and IV oxaliplatin with intraperitoneal docetaxel in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
intravenous (IV) docetaxel and intraperitoneal (IP) oxaliplatin
Drug: intravenous docetaxel with intraperitoneal oxaliplatin
IV docetaxel 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs.
Experimental: 2
intravenous (IV) oxaliplatin and intraperitoneal(IP) docetaxel
Drug: intravenous oxaliplatin with intraperitoneal docetaxel
IV oxaliplatin 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs.

Detailed Description:

This is a non-randomized, open-label Phase I trial in patients with previously treated, recurrent ovarian, primary peritoneal, or fallopian tube cancer. Patients may have either platinum -sensitive (relapse > 12 months from primary therapy) or platinum-resistant (relapse ≤ 12 months from primary therapy) disease.

Up to 20 patients will be enrolled into each of the following arms:

  • Arm 1 patients will receive intravenous docetaxel at standard dosing of 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin on day #2 until maximum tolerated dose is achieved.
  • Arm 2 patients will receive intravenous oxaliplatin at standard dosing of 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel on day #2 until maximum tolerated dose is achieved.

Treatment will be repeated every 3 weeks until disease progression, intolerable toxicity.

  Eligibility

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

Inclusion Criteria:

  • Recurrent histologically confirmed platinum-sensitive or platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer
  • Subjects may not have had > 3 prior regimens and must not have had a platinum or taxane agent within the past 6 months. Last chemotherapy must have been > 4 weeks prior to enrollment. Subjects may not have had prior whole abdomen or pelvic radiation. Patients may not have had > 6 cycles of an alkylating agent or > 450 mg/m2 of doxorubicin.
  • ECOG Performance Score of ≤2 (Appendix A)
  • Adequate bone marrow as evidenced by:

    • Absolute neutrophil count > or equal to 1,500/uL
    • Hemoglobin > or equal to 8 g/dl
    • Platelet count > or equal to 100,000/uL
  • Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL
  • Adequate hepatic function as evidenced by:

    • Serum total bilirubin < 1.5 mg/dL
    • Alk Phos, AST/ALT must be < 3x ULN or <5x ULN if hepatic mets.
    • AST/ALT < 3X the ULN for the reference lab
  • Patients must be recovered from both the acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
  • Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
  • Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria:

  • Patients with an active infection or with a fever > 101.30 F within 3 days of the first scheduled day of protocol treatment
  • Patients with active extra-abdominal metastases
  • Patients with active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the trial
  • History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin or cervical intra-epithelial neoplasia
  • Patients with known hypersensitivity to any of the components of docetaxel or oxaliplatin
  • Patients who received pelvic or abdominal radiotherapy
  • Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
  • Peripheral neuropathy ≤ Grade 2
  • Patients who are pregnant or lactating
  • Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
  • History of allogeneic transplant
  • Known HIV or Hepatitis B or C (active, previously treated or both)
  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: NCT00692900

Contacts
Contact: Vick Gilchrist, RN 412-641-4365 gilchristvb@upmc.edu

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Vicki Gilchrist, RN    412-641-4365    gilchristvb@upmc.edu   
Contact: Carol Onufer, RN    412-641-3133    onuferc@mail.magee.edu   
Sub-Investigator: Joseph Kelley, MD         
Sub-Investigator: Paniti Sukumvanich, MD         
Sub-Investigator: Thomas Krivak, MD         
Sub-Investigator: Alexander Olawaiye, MD         
Sub-Investigator: Scott Richard, MD         
Sponsors and Collaborators
University of Pittsburgh
Sanofi
Investigators
Principal Investigator: Robert P Edwards, MD University of Pittsburgh
Principal Investigator: Kristin Zorn, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Robert Edwards, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00692900     History of Changes
Other Study ID Numbers: OX-06-009
Study First Received: June 4, 2008
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Genital Diseases, Female
Fallopian Tube Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Docetaxel
Oxaliplatin
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014