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

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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
• Intervention / Treatment: Drug: intravenous docetaxel with intraperitoneal oxaliplatin; Drug: intravenous oxaliplatin with intraperitoneal docetaxel

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess quality of life	18 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Sanofi
• Investigators: Principal Investigator: Robert P Edwards, MD, University of Pittsburgh Medical Center; Principal Investigator: Kristin Zorn, MD, University of Pittsburgh Medical Center

Publications and helpful links

Helpful Links

• The University of Pittsburgh Office of Clinical Research (OCR) has developed a website for investigators to list human subject research studies with a brief description of the study, basic eligibility criteria and contact information.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: June 4, 2008
• First Submitted That Met QC Criteria: June 5, 2008
• First Posted (Estimate): June 6, 2008

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Adnexal Diseases; Fallopian Tube Diseases; Fallopian Tube Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Oxaliplatin
• Other Study ID Numbers: OX-06-009