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

• ClinicalTrials.gov Identifier: NCT00692900
• Recruitment Status: Completed
• First Posted: June 6, 2008
• Last Update Posted: February 2, 2016
• Sponsor: University of Pittsburgh
• Collaborator: Sanofi
• Information provided by (Responsible Party): Robert Edwards, University of Pittsburgh

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer	Drug: intravenous docetaxel with intraperitoneal oxaliplatin; Drug: intravenous oxaliplatin with intraperitoneal docetaxel	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: December 2008
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. To assess quality of life [ Time Frame: 18 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

Locations

United States, Pennsylvania

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Sanofi

Investigators

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

More Information

Additional Information:

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. 

• Responsible Party: Robert Edwards, Principal Investigator, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00692900 History of Changes
• Other Study ID Numbers: OX-06-009
• First Posted: June 6, 2008
• Last Update Posted: February 2, 2016
• Last Verified: January 2016

Additional relevant MeSH terms:

Oxaliplatin; Fallopian Tube Neoplasms; Neoplasms by Site; Neoplasms; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms; Fallopian Tube Diseases; Docetaxel; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action