A Phase II Evaluation of ABT-888 (IND# 77840, NCI Supplied Agent: ABT-888, NSC #737664), Topotecan (NSC #609699) and Filgrastim or Pegfilgrastim in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix

Medical Professionals

http://www.clinicaltrials.gov/ct2/show/NCT01266447?term=GOG-0127&recr=Open&rank=1

Explanation of Eligibility Criteria

DISEASE CHARACTERISTICS:

• Patients must have persistent or recurrent squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma, or non-squamous cell carcinoma of the cervix with documented disease progression

  • Histological documentation of the original primary tumor is required via the pathology report

• All patients must have measurable disease as defined by RECIST 1.1

  • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded)
  • Each lesion must be ≥ 10 mm when measured by CT, MRI, or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray
  • Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI

• Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1

  • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy

• Patients must not be eligible for a higher priority GOG protocol, if one exists

  • In general, this would refer to any active GOG phase III protocol or rare tumor protocol for the same patient population

• Patients MUST have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent squamous or non-squamous cell carcinoma of the cervix

  • Chemotherapy administered concurrently with primary radiation is not counted as a systemic chemotherapy regimen (e.g., weekly cisplatin)
  • Adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen (e.g.; paclitaxel and carboplatin for up to 4 cycles)
• Patients are required to have prior pelvic radiation (for patients who are registered during the safety lead-in portion of this protocol)
• Patients MUST not be eligible for further curative intent surgical or pelvic radiation treatment for management of recurrent or persistent disease as determined by treating physicians
• Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases (treated or untreated) are excluded

PATIENT CHARACTERISTICS:

• Patients must have a GOG performance status of 0, 1, or 2
• Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL
• Platelets greater than or equal to 100,000/mcL
• Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
• Bilirubin less than or equal to 1.5 x ULN
• AST and ALT less than or equal to 3 x ULN
• Alkaline phosphatase less than or equal to 2.5 x ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• Patients must have the ability to swallow pills whole
• Patients should be free of active infection requiring antibiotics
• Neuropathy (sensory and motor) less than or equal to grade 1
• Patient with a history of other invasive malignancies, with the exception of non-melanoma skin cancer or cancer of the breast, head and neck, or skin, are excluded if there is any evidence of other malignancy being present within the last three years
• Patients with history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within six months of the first date of treatment on this study are excluded

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Patients are excluded who have had prior therapy with ABT-888 (veliparib), poly (ADP)-ribose polymerase inhibitors, or topotecan
• Patients are excluded if their previous cancer treatment contraindicates this protocol therapy

• Any prior radiation therapy must be completed at least 4 weeks prior to registration

  • Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of cervical cancer within the last three years are excluded

• Any other prior therapy directed at the malignant tumor, including chemotherapy, biological, and immunologic agents must be discontinued at least three weeks prior to registration

  • All side effects must have resolved to ≤ grade 1 or stabilized, prior to enrolling on this study

• Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of cervical cancer within the last three years are excluded

  • Patients may have received prior adjuvant chemotherapy for cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
• Patients must have NOT received more than one previous cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)

• Patients are allowed to have received, but are not required to have received, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition:

  • Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
• Recovered from effects of recent surgery, radiotherapy, or chemotherapy

• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration

  • Continuation of hormone replacement therapy is permitted

• Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration

  • All side effects must have resolved to ≤ grade 1 or stabilized, prior to enrolling on this study
• Patients may NOT receive amifostine or other protective agents

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please call our Clinical Research Center at 407.303.2059 for additional information.

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