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

NCT00692900 | Completed Phase 1 DMC

• 1 other identifier: OX-06-009
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Outcome Measures

Primary Outcomes (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.

  18 months

Secondary Outcomes (1)

• To assess quality of life

  18 months

Study Arms (2)

1

EXPERIMENTAL

intravenous (IV) docetaxel and intraperitoneal (IP) oxaliplatin

Drug: intravenous docetaxel with intraperitoneal oxaliplatin

2

EXPERIMENTAL

intravenous (IV) oxaliplatin and intraperitoneal(IP) docetaxel

Drug: intravenous oxaliplatin with intraperitoneal docetaxel

Interventions

intravenous docetaxel with intraperitoneal oxaliplatin DRUG

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.

1

intravenous oxaliplatin with intraperitoneal docetaxel DRUG

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.

2

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Sanofi: collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

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

Study Officials

• Robert P Edwards, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

• Kristin Zorn, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

US (1)